Trial Outcomes & Findings for A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH (NCT NCT04048135)

Last Updated: 2024-04-02

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

101 participants

Primary outcome timeframe

Up to 113 days

Results posted on

2024-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1: Pegozafermin 3 Milligrams (mg) Weekly (QW) Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W) Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Overall Study STARTED	6	12	11	10	14	9	19	20
Overall Study Received 1 Dose of Study Drug	6	12	11	10	14	9	19	20
Overall Study Safety Analysis Set	7	12	11	10	14	9	18	20
Overall Study COMPLETED	5	11	10	7	13	8	18	19
Overall Study NOT COMPLETED	1	1	1	3	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Pegozafermin 3 Milligrams (mg) Weekly (QW) Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W) Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Overall Study Protocol Violation	0	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	1	1	1	2	0	0	1	1
Overall Study Adverse Event	0	0	0	1	1	0	0	0

Baseline Characteristics

A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Pegozafermin 3 mg QW n=6 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=19 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW n=20 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.	Total n=101 Participants Total of all reporting groups
Age, Continuous	56.13 years STANDARD_DEVIATION 8.23 • n=5 Participants	49.50 years STANDARD_DEVIATION 11.45 • n=7 Participants	51.47 years STANDARD_DEVIATION 13.39 • n=5 Participants	51.96 years STANDARD_DEVIATION 9.83 • n=4 Participants	51.22 years STANDARD_DEVIATION 8.14 • n=21 Participants	52.46 years STANDARD_DEVIATION 8.73 • n=8 Participants	52.62 years STANDARD_DEVIATION 8.99 • n=8 Participants	58.44 years STANDARD_DEVIATION 9.07 • n=24 Participants	52.97 years STANDARD_DEVIATION 1.81 • n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	1 Participants n=8 Participants	12 Participants n=8 Participants	15 Participants n=24 Participants	65 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	36 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants	9 Participants n=8 Participants	16 Participants n=8 Participants	5 Participants n=24 Participants	79 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	15 Participants n=24 Participants	22 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants	9 Participants n=8 Participants	17 Participants n=8 Participants	20 Participants n=24 Participants	94 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 113 days

Population: The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=7 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Number of Participants With Treatment-emergent Adverse Event (TEAEs)	6 Participants	4 Participants	7 Participants	7 Participants	8 Participants	8 Participants	8 Participants	—

PRIMARY outcome

Timeframe: Up to 162 days

Population: The Full Analysis Set included all enrolled participants in Part 2 who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=20 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 2: Number of Participants With TEAEs	18 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Predose and up to 168 hours postdose on Day 29

Population: The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=6 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Maximum Observed Serum Concentration (Cmax) of Pegozafermin	103 ng/mL Interval 59.0 to 156.0	439 ng/mL Interval 238.0 to 852.0	901 ng/mL Interval 200.0 to 1281.0	1166 ng/mL Interval 566.0 to 2243.0	649 ng/mL Interval 160.0 to 1300.0	1674 ng/mL Interval 1300.0 to 2791.0	—	—

PRIMARY outcome

Timeframe: Predose and up to 168 hours postdose on Day 29

Population: The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=6 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Pegozafermin	11879 ng*hour/mL Interval 7350.0 to 17778.0	42576 ng*hour/mL Interval 24394.0 to 70300.0	95765 ng*hour/mL Interval 24822.0 to 138904.0	112632 ng*hour/mL Interval 57880.0 to 231937.0	78761 ng*hour/mL Interval 20520.0 to 155994.0	209436 ng*hour/mL Interval 153404.0 to 287414.0	—	—

PRIMARY outcome

Timeframe: Predose and up to 168 hours postdose on Day 29

Population: The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=6 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Time to Peak Serum Concentration (Tmax) of Pegozafermin	59.5 hr Interval 47.3 to 72.0	48.0 hr Interval 18.6 to 58.8	48.0 hr Interval 34.7 to 72.1	48.1 hr Interval 46.3 to 63.4	72.0 hr Interval 47.5 to 95.2	48.0 hr Interval 45.2 to 71.6	—	—

PRIMARY outcome

Timeframe: Predose and up to 168 hours postdose on Day 29

Population: The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=6 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Terminal Elimination Half-life (t1/2) of Pegozafermin	57.1 hr Interval 54.0 to 75.3	46.3 hr Interval 36.1 to 67.7	68.1 hr Interval 50.8 to 114.0	53.0 hr Interval 27.9 to 62.2	54.4 hr Interval 45.5 to 70.4	53.2 hr Interval 37.4 to 62.2	—	—

PRIMARY outcome

Timeframe: Day 141

Population: The Histology Biopsy Analysis Set included all enrolled participants who received at least 1 dose of study intervention and who had both baseline (screening or eligible historical) and post-baseline biopsies.

NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranges from of 0 to 8, with higher scores indicating worse disease severity. Worsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH Clinical Research Network (CRN) fibrosis score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=19 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 2: Number of Participants With at Least a 2-point Improvement in NAFLD Activity Score (NAS) With at Least a 1-point Improvement in Ballooning or Lobular Inflammation, and no Worsening of Fibrosis	12 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 113 days

Number of participants with anti-pegozafermin antibodies (ADA) with status as ADA positive has been reported.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=7 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Number of Participants With a Positive Anti-Drug Antibodies (ADA) Response to Pegozafermin	1 Participants	9 Participants	7 Participants	7 Participants	11 Participants	6 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Part 1: Baseline, Day 85; Part 2: Baseline, Day 141

Population: The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Parts 1 and 2. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=5 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=11 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=10 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=7 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=13 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=8 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW n=19 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Parts 1 and 2: Percent Change From Baseline in Body Weight	1.19 Percent change Standard Error 1.06	2.59 Percent change Standard Error 0.74	2.47 Percent change Standard Error 0.79	-0.80 Percent change Standard Error 0.86	2.11 Percent change Standard Error 0.69	2.64 Percent change Standard Error 0.86	1.38 Percent change Standard Error 0.59	-3.10 Percent change Standard Error 0.83

SECONDARY outcome

Timeframe: Part 1: Baseline, Day 92; Part 2: Baseline, Day 141

LS Mean was calculated using MMRM.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=6 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=19 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW n=20 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) Triglycerides	-22.74 Percent change Standard Error 11.53	-23.95 Percent change Standard Error 7.74	-17.71 Percent change Standard Error 8.20	-27.63 Percent change Standard Error 9.66	-28.49 Percent change Standard Error 8.62	-20.71 Percent change Standard Error 9.74	-2.21 Percent change Standard Error 6.23	-25.30 Percent change Standard Error 5.66
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) HDLc	18.17 Percent change Standard Error 5.43	11.19 Percent change Standard Error 3.68	9.20 Percent change Standard Error 3.92	2.90 Percent change Standard Error 4.50	20.10 Percent change Standard Error 3.73	9.79 Percent change Standard Error 4.56	1.96 Percent change Standard Error 2.97	22.65 Percent change Standard Error 5.58
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) Non HDLc	-6.31 Percent change Standard Error 6.45	-13.87 Percent change Standard Error 4.61	-1.92 Percent change Standard Error 4.74	-16.32 Percent change Standard Error 5.51	-7.75 Percent change Standard Error 4.38	-6.34 Percent change Standard Error 5.39	1.18 Percent change Standard Error 3.56	-17.12 Percent change Standard Error 3.53
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) LDLc	-6.17 Percent change Standard Error 7.38	-13.45 Percent change Standard Error 5.29	2.59 Percent change Standard Error 5.41	-16.46 Percent change Standard Error 6.34	-5.02 Percent change Standard Error 5.06	-4.11 Percent change Standard Error 6.20	1.15 Percent change Standard Error 4.08	-12.36 Percent change Standard Error 4.80
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) HbA1C	7.36 Percent change Standard Error 4.05	1.80 Percent change Standard Error 2.84	3.05 Percent change Standard Error 2.99	-3.66 Percent change Standard Error 3.42	-1.85 Percent change Standard Error 2.60	6.89 Percent change Standard Error 3.43	0.61 Percent change Standard Error 2.28	-7.23 Percent change Standard Error 1.66
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) Alanine Transaminase	-16.87 Percent change Standard Error 10.62	-26.65 Percent change Standard Error 6.99	-26.73 Percent change Standard Error 7.40	-43.69 Percent change Standard Error 8.55	-18.83 Percent change Standard Error 6.38	-39.84 Percent change Standard Error 8.42	-4.18 Percent change Standard Error 5.47	-45.80 Percent change Standard Error 3.86
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) Aspartate Aminotransferase	-29.36 Percent change Standard Error 9.47	-19.90 Percent change Standard Error 6.15	-15.10 Percent change Standard Error 6.52	-37.88 Percent change Standard Error 7.52	-11.41 Percent change Standard Error 5.63	-25.32 Percent change Standard Error 7.43	-4.40 Percent change Standard Error 4.85	-47.28 Percent change Standard Error 3.54
Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3) Pro-C3	-19.71 Percent change Standard Error 14.53	-18.79 Percent change Standard Error 9.02	1.08 Percent change Standard Error 9.38	-27.67 Percent change Standard Error 11.20	-11.18 Percent change Standard Error 8.19	-12.76 Percent change Standard Error 11.22	3.26 Percent change Standard Error 7.02	-19.52 Percent change Standard Error 3.28

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: The analysis set included all randomized participants who received at least 1 dose of investigational product and who had measurable post-baseline PD data in Part 1. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

LS Mean was calculated using MMRM. HOMA-IR value was calculated by multiplying fasting Glucose (mg/dL) with fasting Insulin (uIU/ml) and then dividing by 405.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=1 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=3 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=6 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=7 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=11 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=5 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=11 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Percent Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Day 92	10.37 Percent change Standard Error 51.30	7.40 Percent change Standard Error 30.62	37.07 Percent change Standard Error 20.87	-41.42 Percent change Standard Error 19.48	-4.57 Percent change Standard Error 15.57	-41.11 Percent change Standard Error 23.39	-0.09 Percent change Standard Error 15.72	—

SECONDARY outcome

Timeframe: Baseline, Day 92

LS Mean was calculated using MMRM.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=5 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=11 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=10 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=7 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=13 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=7 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Percent Change From Baseline in Adiponectin at Day 92	37.65 Percent change Standard Error 14.48	25.46 Percent change Standard Error 9.88	29.09 Percent change Standard Error 10.47	60.85 Percent change Standard Error 12.00	23.11 Percent change Standard Error 9.07	24.14 Percent change Standard Error 12.10	-4.25 Percent change Standard Error 7.80	—

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Part 1. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

LS Mean was calculated using MMRM.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=5 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=7 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=10 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=6 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=9 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=7 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=16 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Percent Change From Baseline in Free Fatty Acid at Day 92	28.70 Percent change Standard Error 24.68	50.20 Percent change Standard Error 21.05	27.08 Percent change Standard Error 17.76	51.58 Percent change Standard Error 22.08	43.85 Percent change Standard Error 18.17	56.12 Percent change Standard Error 20.81	20.91 Percent change Standard Error 13.96	—

SECONDARY outcome

Timeframe: Baseline, Day 50

LS Mean was calculated using MMRM. Adipo-IR was derived from fasting insulin and free fatty acid.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=4 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=4 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=4 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=7 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=8 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=6 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=14 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 1: Percent Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR) at Day 50	-6.12 Percent change Standard Error 61.71	82.00 Percent change Standard Error 59.79	3.28 Percent change Standard Error 60.01	78.40 Percent change Standard Error 46.41	-25.96 Percent change Standard Error 42.75	-10.36 Percent change Standard Error 50.33	-15.82 Percent change Standard Error 32.62	—

SECONDARY outcome

Timeframe: Part 1: Baseline, Day 92; Part 2: Baseline, Day 141

LS Mean was calculated using MMRM.

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=5 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=11 Participants Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=10 Participants Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=7 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=13 Participants Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=8 Participants Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 Participants Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW n=19 Participants Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Parts 1 and 2: Percent Change From Baseline in Liver Fat as Assessed Via Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)	-36.94 Percent change Standard Error 11.01	-49.62 Percent change Standard Error 7.73	-36.11 Percent change Standard Error 8.14	-60.39 Percent change Standard Error 9.40	-43.19 Percent change Standard Error 6.99	-50.39 Percent change Standard Error 9.07	9.77 Percent change Standard Error 6.04	-64.69 Percent change Standard Error 3.38

SECONDARY outcome

Timeframe: Day 141

Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. Worsening of NASH was defined as increase ≥1 point in NAS for ballooning or inflammation. NASH CRN Fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=19 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 2: Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of NASH	5 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 141

Resolution of NASH included the total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH CRN fibrosis score. NASH CRN Fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Outcome measures
Measure	Part 1: Pegozafermin 3 mg QW n=19 Participants Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Part 2: Number of Participants With NASH Resolution Without Worsening of Fibrosis	6 Participants	—	—	—	—	—	—	—

Adverse Events

Part 1: Pegozafermin 3 mg QW

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1: Pegozafermin 9 mg QW

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: Pegozafermin 18 mg QW

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1: Pegozafermin 27 mg QW

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1: Pegozafermin 18 mg Q2W

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 1: Pegozafermin 36 mg Q2W

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 1: Placebo QW or Q2W

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2: Pegozafermin 27 mg QW

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Pegozafermin 3 mg QW n=7 participants at risk Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 participants at risk Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 participants at risk Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 participants at risk Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 participants at risk Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 participants at risk Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 participants at risk Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW n=20 participants at risk Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Infections and infestations COVID-19	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.

Other adverse events

Other adverse events
Measure	Part 1: Pegozafermin 3 mg QW n=7 participants at risk Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 9 mg QW n=12 participants at risk Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg QW n=11 participants at risk Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 27 mg QW n=10 participants at risk Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 18 mg Q2W n=14 participants at risk Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Pegozafermin 36 mg Q2W n=9 participants at risk Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.	Part 1: Placebo QW or Q2W n=18 participants at risk Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.	Part 2: Pegozafermin 27 mg QW n=20 participants at risk Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 2/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Cardiac disorders Bundle Branch Block Left	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Endocrine disorders Thyroid Mass	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Eye disorders Eye Discharge	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Eye disorders Vision Blurred	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Abdominal Distension	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Abdominal Pain	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 2/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 4/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Abdominal Tenderness	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	16.7% 2/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Change of Bowel Habit	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Constipation	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	16.7% 2/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 2/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	22.2% 2/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	22.2% 4/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	35.0% 7/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Flatulence	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Gastritis	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Gastrointestinal Sounds Abnormal	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Nausea	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	21.4% 3/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	16.7% 3/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	50.0% 10/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Swollen Tongue	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 4/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Chest Pain	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	14.3% 2/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Fatigue	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 4/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Injection Site Bruising	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Injection Site Erythema	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Injection Site Pain	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Injection Site Pruritus	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Injection Site Reaction	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Oedema Peripheral	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
General disorders Swelling Face	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Immune system disorders Seasonal Allergy	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations COVID-19	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Gastroenteritis	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Gastroenteritis Viral	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Gastrointestinal Infection	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Influenza	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Oral Herpes	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Upper Respiratory Tract Infection	28.6% 2/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Infections and infestations Urinary Tract Infection	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Investigations Alanine Aminotransferase Increased	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Investigations Muscle Enzyme Increased	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Investigations Weight Increased	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	15.0% 3/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Metabolism and nutrition disorders Glucose Tolerance Impaired	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 1/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Metabolism and nutrition disorders Increased Appetite	57.1% 4/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	16.7% 2/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 2/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	14.3% 2/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	9.1% 1/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Nervous system disorders Dizziness	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	11.1% 2/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Nervous system disorders Dysgeusia	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	14.3% 2/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Nervous system disorders Headache	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	20.0% 2/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	14.3% 2/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	22.2% 2/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.0% 1/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Nervous system disorders Neuropathy Peripheral	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Psychiatric disorders Insomnia	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Renal and urinary disorders Polyuria	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	8.3% 1/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Reproductive system and breast disorders Menstrual Disorder	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	5.6% 1/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	7.1% 1/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Skin and subcutaneous tissue disorders Rash	0.00% 0/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 1/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	10.0% 2/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Vascular disorders Hypotension	14.3% 1/7 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/12 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/11 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/10 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/14 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/9 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/18 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.	0.00% 0/20 • Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2). The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis. MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.

Additional Information

Clinical Director

89bio, Inc.

Phone: 1-858-261-8838

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place