Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis (NCT NCT01831427)

Last Updated: 2021-02-01

Results Overview

TEAEs are any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

74 participants

Primary outcome timeframe

SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days

Results posted on

2021-02-01

Participant Flow

Participants were enrolled at study sites in the United States, and Europe. The first participant was screened on 28 March 2013. The last study visit occurred on 06 February 2015.

124 participants were screened.

Participant milestones

Participant milestones
Measure	Andecaliximab 0.3 mg/kg IV Single Ascending Dose (SAD) Participants received a single intravenous (IV) infusion of andecaliximab 0.3 milligrams per kilogram (mg/kg) on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV Multiple Ascending Doses (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single subcutaneous (SC) doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
Overall Study STARTED	5	5	5	5	4	8	8	8	8	10	8
Overall Study COMPLETED	5	4	5	4	4	7	6	7	8	9	5
Overall Study NOT COMPLETED	0	1	0	1	0	1	2	1	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Andecaliximab 1.0 mg/kg IV (SAD) Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab 0.3 mg/kg IV Multiple Ascending Doses (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single subcutaneous (SC) doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
Overall Study Adverse Event	1	0	1	0	1	0	2
Overall Study Investigator's Discretion	0	1	0	0	0	0	0
Overall Study Withdrew Consent	0	0	0	2	0	1	1

Baseline Characteristics

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Placebo Pooled (SAD) n=4 Participants Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 150 mg SC (Adaptive MAD) n=10 Participants Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Placebo Pooled (MAD) n=8 Participants Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.	Total n=74 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 11.3 • n=5 Participants	37 years STANDARD_DEVIATION 11.3 • n=7 Participants	45 years STANDARD_DEVIATION 15.4 • n=5 Participants	42 years STANDARD_DEVIATION 12.9 • n=4 Participants	41 years STANDARD_DEVIATION 15.1 • n=21 Participants	42 years STANDARD_DEVIATION 13.9 • n=10 Participants	39 years STANDARD_DEVIATION 11.7 • n=115 Participants	38 years STANDARD_DEVIATION 13.7 • n=24 Participants	50 years STANDARD_DEVIATION 9.8 • n=42 Participants	48 years STANDARD_DEVIATION 8.8 • n=42 Participants	44 years STANDARD_DEVIATION 15.8 • n=42 Participants	43 years STANDARD_DEVIATION 12.4 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	38 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	5 Participants n=115 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	36 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=10 Participants	8 Participants n=115 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	10 Participants n=42 Participants	8 Participants n=42 Participants	74 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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Race · 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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or 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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Race · White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	7 Participants n=115 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	8 Participants n=42 Participants	8 Participants n=42 Participants	64 Participants n=42 Participants
Race/Ethnicity, Customized Race · Other	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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Race · Not Permitted	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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days

Population: The Safety Analysis Set included participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) n=20 Participants Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) n=4 Participants Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) n=8 Participants Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) n=32 Participants Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) n=10 Participants Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) n=42 Participants Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) n=8 Participants Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events (TEAEs) (SAD/MAD)	0.0 percentage of participants	20.0 percentage of participants	20.0 percentage of participants	60.0 percentage of participants	25.0 percentage of participants	25.0 percentage of participants	25.0 percentage of participants	75.0 percentage of participants	62.5 percentage of participants	62.5 percentage of participants	56.3 percentage of participants	50.0 percentage of participants	54.8 percentage of participants	62.5 percentage of participants

PRIMARY outcome

Timeframe: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43

Population: Participants in the PK Analysis Set (who received at least 1 dose of study drug and had at least 1 non-missing post dose concentration value for the corresponding analyte in plasma) for the SAD cohorts were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
Pharmacokinetic (PK) Parameter: Cmax (SAD)	9.4 micrograms per milliliter (μg/mL) Standard Deviation 3.28	32.7 micrograms per milliliter (μg/mL) Standard Deviation 11.08	77.8 micrograms per milliliter (μg/mL) Standard Deviation 20.67	210.0 micrograms per milliliter (μg/mL) Standard Deviation 102.60	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Days 1 and 29, Predose on Days 8 and 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Days 1, and 29, Predose on Days 8 and 36

Population: Participants in the PK Analysis Set for MAD cohort (with available data) and Adaptive MAD cohort were analyzed.

Cmax is defined as the maximum concentration of drug over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) n=9 Participants Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
PK Parameter: Cmax (MAD) Day 1	9.0 μg/mL Standard Deviation 3.23	33.7 μg/mL Standard Deviation 26.43	57.1 μg/mL Standard Deviation 13.66	95.3 μg/mL Standard Deviation 28.93	NA μg/mL Standard Deviation NA Not evaluated at Day 1 for the andecaliximab 150 mg SC group.	—	—	—	—	—	—	—	—	—
PK Parameter: Cmax (MAD) Day 29	10.3 μg/mL Standard Deviation 5.06	29.0 μg/mL Standard Deviation 10.89	66.6 μg/mL Standard Deviation 15.02	120.8 μg/mL Standard Deviation 21.15	33.5 μg/mL Standard Deviation 42.47	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Day 29; Predose on Day 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Day 29; Predose on Day 36

Population: Participants in the PK Analysis Set for MAD and Adaptive MAD cohorts were analyzed.

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=7 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) n=9 Participants Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
PK Parameter: Ctau (MAD)	NA μg/mL Standard Deviation NA Values were all below the limit of quantitation.	NA μg/mL Standard Deviation NA Values were all below the limit of quantitation.	0.8 μg/mL Standard Deviation 2.36	27.2 μg/mL Standard Deviation 13.99	16.0 μg/mL Standard Deviation 15.99	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43

Population: Participants in the PK Analysis Set for SAD cohorts were analyzed.

AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
PK Parameter: AUCinf (SAD)	9.4 daymicrograms per milliliter(dayμg/mL) Standard Deviation 4.44	66.6 daymicrograms per milliliter(dayμg/mL) Standard Deviation 22.85	240.8 daymicrograms per milliliter(dayμg/mL) Standard Deviation 23.69	817.3 daymicrograms per milliliter(dayμg/mL) Standard Deviation 405.97	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Days 1 and 29; Predose on Days 8 and 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Days 1, and 29; Predose on Days 8 and 36

Population: Participants in the PK Analysis Set for MAD and Adaptive MAD cohorts with available data were analyzed. Concentrations fell below the limit of quantitation early in the dosing interval for some participants in some of the cohorts. Therefore, AUCtau couldn't be adequately estimated and was not included.

AUCtau is defined as the area under the plasma concentration versus time curve over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=7 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=6 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=8 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) n=9 Participants Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
PK Parameter: AUCtau (MAD)	NA day*μg/mL Standard Deviation NA Concentrations in this group fell below the limit of quantitation early in the dosing interval. Therefore, AUCtau couldn't be adequately estimated for all participants.	79.2 day*μg/mL Standard Deviation 53.98	251.8 day*μg/mL Standard Deviation 88.15	784.8 day*μg/mL Standard Deviation 262.5	166.8 day*μg/mL Standard Deviation 164.53	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43

Population: Participants in the PK Analysis Set for SAD cohorts were analyzed.

AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last observable concentration.

Outcome measures

Outcome measures
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 Participants Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
PK Parameter: AUClast (SAD)	7.7 day*μg/mL Standard Deviation 2.54	57.2 day*μg/mL Standard Deviation 26.96	212.4 day*μg/mL Standard Deviation 38.79	750.2 day*μg/mL Standard Deviation 412.42	—	—	—	—	—	—	—	—	—	—

Adverse Events

Andecaliximab 0.3 mg/kg IV (SAD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Andecaliximab 1.0 mg/kg IV (SAD)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Andecaliximab 2.5 mg/kg IV (SAD)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Andecaliximab 5.0 mg/kg IV (SAD)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Andecaliximab IV Combined (SAD)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Pooled (SAD)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Andecaliximab 0.3 mg/kg IV (MAD)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Andecaliximab 1.0 mg/kg IV (MAD)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Andecaliximab 2.5 mg/kg IV (MAD)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Andecaliximab 5.0 mg/kg IV (MAD)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Andecaliximab IV Combined (MAD)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Andecaliximab 150 mg SC (Adaptive MAD)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Andecaliximab IV+SC Combined (MAD)

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo Pooled (MAD)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) n=20 participants at risk Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) n=4 participants at risk Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) n=32 participants at risk Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) n=10 participants at risk Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) n=42 participants at risk Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) n=8 participants at risk Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Immune system disorders Hypersensitivity	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Cytomegalovirus infection	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Andecaliximab 0.3 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 0.3 mg/kg on Day 1.	Andecaliximab 1.0 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.	Andecaliximab 2.5 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.	Andecaliximab 5.0 mg/kg IV (SAD) n=5 participants at risk Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.	Andecaliximab IV Combined (SAD) n=20 participants at risk Participants who received a single IV infusion of andecaliximab (0.3, 1.0, 2.5 and 5.0 mg/kg on Day 1) were combined in this arm.	Placebo Pooled (SAD) n=4 participants at risk Participants received a single IV infusion of placebo on Day 1.	Andecaliximab 0.3 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 0.3 mg/kg on Days 1, 15, and 29.	Andecaliximab 1.0 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.	Andecaliximab 2.5 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.	Andecaliximab 5.0 mg/kg IV (MAD) n=8 participants at risk Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.	Andecaliximab IV Combined (MAD) n=32 participants at risk Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) were combined in this arm.	Andecaliximab 150 mg SC (Adaptive MAD) n=10 participants at risk Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.	Andecaliximab IV+SC Combined (MAD) n=42 participants at risk Participants who received 3 single IV infusions of andecaliximab (0.3, 1.0, 2.5, 5.0 mg/kg on Days 1, 15, and 29) and 5 single SC dose of andecaliximab (150 mg on Days 1, 8, 15, 22, and 29) were combined in this arm.	Placebo Pooled (MAD) n=8 participants at risk Participants received 3 single IV infusions of placebo on Days 1, 15, and 29.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	37.5% 3/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	15.6% 5/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	11.9% 5/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	37.5% 3/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Cardiac disorders Wandering pacemaker	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Lacrimation increased	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Salivary gland pain	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	9.4% 3/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.1% 3/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Gingivitis	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 1/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	9.4% 3/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.1% 3/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Otitis media	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Weight decreased	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	20.0% 1/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	5.0% 1/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	6.2% 2/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.1% 3/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 2/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Tension headache	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.5% 1/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.1% 1/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/5 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/20 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/4 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/32 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.0% 1/10 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.4% 1/42 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/8 • SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days. The Safety Analysis Set included participants who received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years.
Publication restrictions are in place

Restriction type: OTHER