Trial Outcomes & Findings for Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL (NCT NCT02361346)

Last Updated: 2022-08-18

Results Overview

The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Days 1, 3, 5, 8, 10 and 12

Results posted on

2022-08-18

Participant Flow

This 4-part study evaluated safety, pharmacodynamics and efficacy of MT-3724 in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Part 1 was multiple ascending dose study and Parts 2, 3 and 4 were multi-center, multinational, open-label, single-arm evaluation of MT-3724 administered as monotherapy in repeat doses.

A total of 27 participants were enrolled in Parts 1 and 2 and 11 participants in Part 3. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. The study was terminated as no participants in Part 3 showed a response and the potential risks outweighed potential benefit.

Participant milestones

Participant milestones
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort either received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 3 MT-3724 was administered at a dose of 50μg/kg/dose via IV infusion for all participants
Part 1 and 2 ( Up to Day 112) STARTED	3	3	3	4	2	6	6	0
Part 1 and 2 ( Up to Day 112) COMPLETED	3	3	3	3	0	6	6	0
Part 1 and 2 ( Up to Day 112) NOT COMPLETED	0	0	0	1	2	0	0	0
Part 3 (Up to Day 112) STARTED	0	0	0	0	0	0	0	11
Part 3 (Up to Day 112) COMPLETED	0	0	0	0	0	0	0	0
Part 3 (Up to Day 112) NOT COMPLETED	0	0	0	0	0	0	0	11
Part 4 (Up to Day 112) STARTED	0	0	0	0	0	0	0	0
Part 4 (Up to Day 112) COMPLETED	0	0	0	0	0	0	0	0
Part 4 (Up to Day 112) NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 3 MT-3724 was administered at a dose of 50μg/kg/dose via IV infusion for all participants
Part 1 and 2 ( Up to Day 112) Death	1	0	0
Part 1 and 2 ( Up to Day 112) Adverse Event	0	2	0
Part 3 (Up to Day 112) Adverse Event	0	0	1
Part 3 (Up to Day 112) Withdrawal by Subject	0	0	1
Part 3 (Up to Day 112) Disease progression (radiographic per lugano)	0	0	7
Part 3 (Up to Day 112) Clinical disease progression	0	0	2

Baseline Characteristics

Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 3: All MT-3724 Treated Participants n=11 Participants MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants	Part 4: All MT-3724 Treated Participants Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle	Total n=38 Participants Total of all reporting groups
Age, Continuous	73.3 Years STANDARD_DEVIATION 6.43 • n=5 Participants	70.7 Years STANDARD_DEVIATION 8.74 • n=7 Participants	64.3 Years STANDARD_DEVIATION 14.01 • n=5 Participants	57.8 Years STANDARD_DEVIATION 16.66 • n=4 Participants	65.0 Years STANDARD_DEVIATION 4.24 • n=21 Participants	67.2 Years STANDARD_DEVIATION 4.40 • n=8 Participants	59.3 Years STANDARD_DEVIATION 10.58 • n=8 Participants	57.5 Years STANDARD_DEVIATION 14.77 • n=24 Participants	—	64.4 Years STANDARD_DEVIATION 5.90 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	3 Participants n=24 Participants	—	20 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	8 Participants n=24 Participants	—	18 Participants n=42 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	11 Participants n=24 Participants	—	34 Participants n=42 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	—	2 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	—	2 Participants n=42 Participants

PRIMARY outcome

Timeframe: Days 1, 3, 5, 8, 10 and 12

Population: Safety Set comprises of all participants who received any amount of MT-3724

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Part 1 and 2 : Days 1, 3 and 12

Population: Pharmacokinetic Analysis Set (PAS). All subjects from the Safety Set with sufficient serum concentration data to determine the primary PK parameters. Only those participants with data available at specified timepoints were analyzed. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=1 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=7 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=9 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=2 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)

PRIMARY outcome

Timeframe: Part 1 and 2: Days 1, 3 and 12

Population: Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Blood samples were collected at indicated timepoints for the determination of tmax.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)

PRIMARY outcome

Timeframe: Part 1 and 2: Days 1, 3 and 12

Population: Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 AUC (0-4)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 AUC (0-infinity)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 AUClast	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA h*ng/ml Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)

PRIMARY outcome

Timeframe: Part 1 and 2: Days 1, 3 and 12

Population: Pharmacokinetic Analysis Set. Part 2 was analyzed as a single-arm as data was not collected for each dose level separately.

Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Half Life (t1/2) of MT-3724	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)

PRIMARY outcome

Timeframe: Part 1 and 2: Days 1, 3 and 12

Population: Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Volume of Distribution (Vz) of MT-3724	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)

PRIMARY outcome

Timeframe: Part 1 and 2: Days 1, 3 and 12

Population: Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Clearance (CL) of MT-3724	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	NA Liters per hour Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)

PRIMARY outcome

Timeframe: Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)

Population: Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes Cycle 3 Day 1	67.0 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	134 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	60.0 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	1170 10^3 cells per microliter Standard Deviation 1965.6	—	34.0 10^3 cells per microliter Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant	—
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes Cycle 1 Day 8	114 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	325 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	244 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	57.7 10^3 cells per microliter Standard Deviation 91.166	—	126 10^3 cells per microliter Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant	—
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes Cycle 1 Day 23	143 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	104 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	131 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	—	—	67.0 10^3 cells per microliter Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant	—
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes Cycle 5 Day 1	132 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	180 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	53.0 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	26.0 10^3 cells per microliter Standard Deviation 31.1127	—	39.0 10^3 cells per microliter Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant	—
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes Day 120 (End of study)	79.0 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	184 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	49.0 10^3 cells per microliter Standard Deviation NA Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)	22.87 10^3 cells per microliter Standard Deviation 18.17	—	44.0 10^3 cells per microliter Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant	—

PRIMARY outcome

Timeframe: Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)

Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed Cycle 1 Day 23	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed Cycle 2 Day 1	0 Participants	3 Participants	1 Participants	4 Participants	0 Participants	2 Participants	—
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed Cycle 3 Day 1	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants	—
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed Cycle 4 Day 1	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants	—
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed Cycle 5 Day 1	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed Day 120 (end of study)	2 Participants	2 Participants	1 Participants	4 Participants	0 Participants	3 Participants	—

PRIMARY outcome

Timeframe: Up to Day 45

Population: Safety Set.

An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=11 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs Serious TEAEs	3 Participants	—	—	—	—	—	—
Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs Non-serious TEAEs	11 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 45

Population: Safety Set.

Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=11 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 3: Number of Participants With Clinically Significant Laboratory Parameters	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Set.

Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=11 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 45

Population: Safety Set.

Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=11 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 3: Number Participants With Clinically Significant Vital Signs	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Set.

Physical examination was performed by a physician or a qualified delegate at the investigating site.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=11 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 3: Number of Participants With Clinically Significant Physical Findings	2 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Safety Set comprises of all participants who received any amount of MT-3724. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) n=3 Participants Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2- 10 mcg/kg/Dose n=3 Participants Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3- 20 mcg/kg/Dose n=3 Participants Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4- 50 mcg/kg/Dose n=4 Participants Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5- 100 mcg/kg/Dose n=2 Participants Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6- 75 mcg/kg/Dose n=6 Participants Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 Participants Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs Serious TEAEs	1 Participants	0 Participants	2 Participants	4 Participants	2 Participants	3 Participants	2 Participants
Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs Non-serious TEAEs	3 Participants	3 Participants	3 Participants	4 Participants	2 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination.

Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

DCR defined as percentage of participants who have achieved CR, PR and stable disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of tmax of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Duration of response was defined as the time from the first occurrence of either complete or partial response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were planned to be censored at time of last disease assessment. Only responders (CR or PR) were planned to be included for this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Safety Set. The data was not collected due to early study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Safety Set. The data was not collected due to early study termination

A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Safety Set. The data was not collected due to early study termination

Blood samples were planned to be collected for the analysis of laboratory parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Safety Set. The data was not collected due to early study termination

Vital signs parameters including systolic and diastolic blood pressure, heart rate, respiration rate, body temperature and body weight were planned to be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 26

Population: Safety Set. The data was not collected due to early study termination

Standard resting 12-lead ECG assessments was planned to be performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 26

Population: Safety Set. The data was not collected due to early study termination

Number of participants with any adverse events leading to cardiotoxicity when treated with MT-3724 was planned to be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Overall response rate was defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

DCR was defined as percentage of participants who has achieved CR, PR and stable disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Progression-free survival was defined as the time from study enrollment to the earliest date of disease progression or death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Full Analysis Set. The data was not collected due to early study termination

Overall survival was defined as the time from study enrollment to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of Tmax of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 45

Population: Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Cohort 2: 10 mcg/kg/Dose/Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Cohort 3: 20 mcg/kg/Dose/Day

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Cohort 4: 50 mcg/kg/Dose/Day

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1: Cohort 5: 100 mcg/kg/Dose/Day

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Cohort 6: 75 mcg/kg/Dose/Day

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 3: All MT-3724 Treated Participants

Serious events: 3 serious events

Other events: 11 other events

Deaths: 1 deaths

Part 4: All MT-3724 Treated Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day n=3 participants at risk Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2: 10 mcg/kg/Dose/Day n=3 participants at risk Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3: 20 mcg/kg/Dose/Day n=3 participants at risk Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4: 50 mcg/kg/Dose/Day n=4 participants at risk Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5: 100 mcg/kg/Dose/Day n=2 participants at risk Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6: 75 mcg/kg/Dose/Day n=6 participants at risk Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 participants at risk Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 3: All MT-3724 Treated Participants n=11 participants at risk Participants in this arm received all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle	Part 4: All MT-3724 Treated Participants Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Ascites	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Ileus	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Fatigue	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Oedema	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Oedema peripheral	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Bronchitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Pneumonia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Superinfection	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Viral infection	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypercalcaemia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Aphasia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Psychiatric disorders Anxiety	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Renal and urinary disorders Renal failure acute	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Hypertension	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Fever	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Capillary leak syndrome	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	18.2% 2/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Other adverse events

Other adverse events
Measure	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day n=3 participants at risk Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 2: 10 mcg/kg/Dose/Day n=3 participants at risk Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 3: 20 mcg/kg/Dose/Day n=3 participants at risk Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 4: 50 mcg/kg/Dose/Day n=4 participants at risk Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 5: 100 mcg/kg/Dose/Day n=2 participants at risk Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 1: Cohort 6: 75 mcg/kg/Dose/Day n=6 participants at risk Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) n=6 participants at risk Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Part 3: All MT-3724 Treated Participants n=11 participants at risk Participants in this arm received all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle	Part 4: All MT-3724 Treated Participants Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Respiratory, thoracic and mediastinal disorders Hypocapnia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 4/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Throat irritation	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Phlebitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Rash maculo-papular	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Capillary leak syndrome	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Flushing	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Haematoma	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Hot flush	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Hypertension	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Hypotension	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Lymphoedema	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Vascular disorders Venous thrombosis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 2/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Eye swelling	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Leukopenia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Iron deficiency anemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Angina pectoris	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Cardiomyopathy	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Coronary artery disease	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Myocardial ischaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Palpitations	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Cardiac disorders Tachycardia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Ear and labyrinth disorders Ear disorder	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Diplopia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Eye irritation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Dry eye	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Lacrimation increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Retinal exudates	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Retinal haemorrhage	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Eye disorders Vision blurred	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Ascites	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Asthenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Constipation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 2/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	36.4% 4/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Melaena	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Nausea	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	100.0% 3/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Reflux gastritis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Anemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	45.5% 5/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Asthenia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Chills	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Face oedema	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Fatigue	100.0% 3/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	18.2% 2/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Infusion site irritation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Injection site extravasation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Injection site reaction	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Local swelling	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Malaise	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Mucosal inflammation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Muscular weakness	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	18.2% 2/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Non-cardiac chest pain	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Oedema	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Oedema peripheral	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	100.0% 3/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	100.0% 4/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 4/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	36.4% 4/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Pyrexia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	54.5% 6/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
General disorders Swelling face	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Bronchitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Cellulitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Conjunctivitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Folliculitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Oral candidiasis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Otitis media	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Pharyngitis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Pneumonia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Pyoderma	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Infections and infestations Urinary tract infection	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Injury, poisoning and procedural complications Scratch	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Blood chloride increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Blood lactic acid increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Heart rate increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Lipase increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Lymphocyte count decreased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Neutrophil count decreased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Platelet count decreased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Dysgeusia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Troponin increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations Weight increased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Investigations White blood cell count decreased	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	18.2% 2/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 2/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Gout	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 2/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	36.4% 4/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypocalcaemia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypoglycaemia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	100.0% 2/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	18.2% 2/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Groin pain	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	100.0% 2/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	63.6% 7/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Dizziness	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 2/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	18.2% 2/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Headache	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Horner's syndrome	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Hyperaesthesia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Memory impairment	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Paraesthesia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Presyncope	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Nervous system disorders Somnolence	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 1/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Psychiatric disorders Agitation	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Psychiatric disorders Anxiety	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Psychiatric disorders Depression	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Psychiatric disorders Dysphoria	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Psychiatric disorders Insomnia	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	50.0% 3/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	25.0% 1/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 2/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	16.7% 1/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	27.3% 3/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	33.3% 1/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/3 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/4 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/2 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	0.00% 0/6 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	9.1% 1/11 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.	— 0/0 • Non-serious TEAEs and SAEs were collected up to Day 45. Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade \>=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Additional Information

Study Director

Molecular Templates, Inc.

Phone: 512 930-0304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER