Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248 (NCT NCT04036227)

Last Updated: 2023-10-11

Results Overview

AEs were assessed as 'unlikely', 'possibly' or 'probably' related to the IMP. 'Possibly' and 'probably' were categorized as treatment related.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

72 participants

Primary outcome timeframe

AEs were collected from the start of IMP administration until the end-of-study visit of each part, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).

Results posted on

2023-10-11

Participant Flow

Subjects were recruited from CTC's database of healthy volunteers and from advertising in media (including social media). Screening visits were performed at CTC research clinic. Part I (SAD): Recruitment period started 19JUN2019 and lasted until 15OCT2019. Part II (MAD): Recruitment period started in August 2019 (when first SAD cohorts had been completed) and lasted until 25NOV2019.

Part I (SAD): 92 subjects screened, 48 randomised to 6 dosing groups each of which included placebo. Did not meet the eligibility criteria=12, withdrew consent prior to randomisation=20, reserves=6, other reasons=6. Part II (MAD): 49 subjects screened, 24 randomised to 3 dosing groups each of which included placebo. Did not meet the eligibility criteria=11, withdrew consent prior to randomisation=9, reserve=1, other reasons=4.

Participant milestones

Participant milestones
Measure	Part I (SAD): 1 mg Single dose (actual dose) of 1 mg GS-248 oral solution.	Part I (SAD): 5 mg Single dose (actual dose) of 5 mg GS-248 oral solution.	Part I (SAD): 8 mg Single dose (actual dose) of 8 mg GS-248 oral solution.	Part I (SAD): 40 mg Single dose (actual dose) of 40 mg GS-248 oral solution.	Part I (SAD): 100 mg Single dose (actual dose) of 100 mg GS-248 oral solution.	Part I (SAD): 300 mg Single dose (actual dose) of 300 mg GS-248 oral solution.	Part I (SAD): Placebo Matching placebo oral solution Placebo: Placebo oral solution with the same composition to match active drug	Part II (MAD): 20 mg Multiple ascending doses for 10 days with actual dose of 20 mg. Dose were finally selected based on results from Part I.	Part II (MAD): 60 mg Multiple ascending doses for 10 days with actual dose of 60 mg.	Part II (MAD): 180 mg Multiple ascending doses for 10 days with actual dose of 180 mg.	Part II (MAD): Placebo Matching placebo oral solution Placebo: Placebo oral solution with the same composition to match active drug
Part I (SAD): 1 mg STARTED	6	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 1 mg COMPLETED	6	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 1 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 5 mg STARTED	0	6	0	0	0	0	0	0	0	0	0
Part I (SAD): 5 mg COMPLETED	0	6	0	0	0	0	0	0	0	0	0
Part I (SAD): 5 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 8 mg STARTED	0	0	6	0	0	0	0	0	0	0	0
Part I (SAD): 8 mg COMPLETED	0	0	6	0	0	0	0	0	0	0	0
Part I (SAD): 8 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 40 mg STARTED	0	0	0	6	0	0	0	0	0	0	0
Part I (SAD): 40 mg COMPLETED	0	0	0	6	0	0	0	0	0	0	0
Part I (SAD): 40 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 100 mg STARTED	0	0	0	0	6	0	0	0	0	0	0
Part I (SAD): 100 mg COMPLETED	0	0	0	0	6	0	0	0	0	0	0
Part I (SAD): 100 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part I (SAD): 300 mg STARTED	0	0	0	0	0	6	0	0	0	0	0
Part I (SAD): 300 mg COMPLETED	0	0	0	0	0	6	0	0	0	0	0
Part I (SAD): 300 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part I (SAD): Placebo STARTED	0	0	0	0	0	0	12	0	0	0	0
Part I (SAD): Placebo COMPLETED	0	0	0	0	0	0	12	0	0	0	0
Part I (SAD): Placebo NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part II (MAD): 20 mg STARTED	0	0	0	0	0	0	0	6	0	0	0
Part II (MAD): 20 mg COMPLETED	0	0	0	0	0	0	0	6	0	0	0
Part II (MAD): 20 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part II (MAD): 60 mg STARTED	0	0	0	0	0	0	0	0	6	0	0
Part II (MAD): 60 mg COMPLETED	0	0	0	0	0	0	0	0	6	0	0
Part II (MAD): 60 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part II (MAD): 180 mg STARTED	0	0	0	0	0	0	0	0	0	6	0
Part II (MAD): 180 mg COMPLETED	0	0	0	0	0	0	0	0	0	5	0
Part II (MAD): 180 mg NOT COMPLETED	0	0	0	0	0	0	0	0	0	1	0
Part II (MAD): Placebo STARTED	0	0	0	0	0	0	0	0	0	0	6
Part II (MAD): Placebo COMPLETED	0	0	0	0	0	0	0	0	0	0	6
Part II (MAD): Placebo NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part I (SAD): 1 mg n=6 Participants Single dose of 1 mg GS-248 oral solution.	Part I (SAD): 5 mg n=6 Participants Single dose of 5 mg GS-248 oral solution.	Part I (SAD): 8 mg n=6 Participants Single dose of 8 mg GS-248 oral solution.	Part I (SAD): 40 mg n=6 Participants Single dose of 40 mg GS-248 oral solution.	Part I (SAD): 100 mg n=6 Participants Single dose of 100 mg GS-248 oral solution.	Part I (SAD): 300 mg n=6 Participants Single dose of 300 mg GS-248 oral solution.	Part I (SAD): Placebo n=12 Participants Single dose of matching placebo oral solution.	Part II (MAD): 20 mg n=6 Participants Multiple ascending doses for 10 days with 20 mg.	Part II (MAD): 60 mg n=6 Participants Multiple ascending doses for 10 days with 60 mg.	Part II (MAD): 180 mg n=6 Participants Multiple ascending doses for 10 days with 180 mg.	Part II (MAD): Placebo n=6 Participants Multiple ascending doses for 10 days with matching placebo oral solution.	Total n=72 Participants Total of all reporting groups
Age, Continuous Part I (SAD)	40.7 years STANDARD_DEVIATION 21.5 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	33.7 years STANDARD_DEVIATION 9.8 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	36.8 years STANDARD_DEVIATION 21.4 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	41.8 years STANDARD_DEVIATION 15.9 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	50.7 years STANDARD_DEVIATION 10.8 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	33.7 years STANDARD_DEVIATION 13.0 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	32.4 years STANDARD_DEVIATION 14.1 • n=12 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	—	—	—	—	37.8 years STANDARD_DEVIATION 15.8 • n=48 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.
Age, Continuous Part II (MAD)	—	—	—	—	—	—	—	56.7 years STANDARD_DEVIATION 12.2 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	58.2 years STANDARD_DEVIATION 11.0 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	58.2 years STANDARD_DEVIATION 12.2 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	59.0 years STANDARD_DEVIATION 13.9 • n=6 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.	58.0 years STANDARD_DEVIATION 11.6 • n=24 Participants • Part I (SAD-cohorts) and Part II (MAD-cohorts) analysed separately.
Sex: Female, Male Part I (SAD) · Female	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	1 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	—	—	—	—	20 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Sex: Female, Male Part I (SAD) · Male	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	5 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	9 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	—	—	—	—	28 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Sex: Female, Male Part II (MAD) · Female	—	—	—	—	—	—	—	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	15 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Sex: Female, Male Part II (MAD) · Male	—	—	—	—	—	—	—	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	3 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	9 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Ethnicity (NIH/OMB) Part I (SAD) · Hispanic or Latino	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	1 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	1 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Ethnicity (NIH/OMB) Part I (SAD) · Not Hispanic or Latino	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	5 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	12 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	47 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Ethnicity (NIH/OMB) Part I (SAD) · Unknown or Not Reported	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Ethnicity (NIH/OMB) Part II (MAD) · Hispanic or Latino	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Ethnicity (NIH/OMB) Part II (MAD) · Not Hispanic or Latino	—	—	—	—	—	—	—	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	24 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Ethnicity (NIH/OMB) Part II (MAD) · Unknown or Not Reported	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · American Indian or Alaska Native	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · Asian	2 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	1 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	1 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	4 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · Black or African American	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · White	4 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	5 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	11 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	44 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · More than one race	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) part I (MAD) · Unknown or Not Reported	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · American Indian or Alaska Native	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · Asian	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · Native Hawaiian or Other Pacific Islander	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · Black or African American	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · White	—	—	—	—	—	—	—	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	6 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	24 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · More than one race	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Race (NIH/OMB) Part II (MAD) · Unknown or Not Reported	—	—	—	—	—	—	—	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	0 Participants n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Region of Enrollment Sweden	6 participants n=6 Participants	6 participants n=6 Participants	6 participants n=6 Participants	6 participants n=6 Participants	6 participants n=6 Participants	6 participants n=6 Participants	12 participants n=12 Participants	6 participants n=6 Participants	6 participants n=6 Participants	6 participants n=6 Participants	6 participants n=6 Participants	72 participants n=72 Participants
BMI Part I (SAD)	22.3 kg/m^2 STANDARD_DEVIATION 2.6 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	25.2 kg/m^2 STANDARD_DEVIATION 3.9 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	25.2 kg/m^2 STANDARD_DEVIATION 3.4 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	25.7 kg/m^2 STANDARD_DEVIATION 3.4 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	26.0 kg/m^2 STANDARD_DEVIATION 2.2 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	22.0 kg/m^2 STANDARD_DEVIATION 2.0 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	24.0 kg/m^2 STANDARD_DEVIATION 3.0 • n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	—	—	—	—	24.4 kg/m^2 STANDARD_DEVIATION 3.2 • n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
BMI Part II (MAD)	—	—	—	—	—	—	—	26.0 kg/m^2 STANDARD_DEVIATION 1.3 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	23.5 kg/m^2 STANDARD_DEVIATION 2.7 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	24.3 kg/m^2 STANDARD_DEVIATION 1.6 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	25.8 kg/m^2 STANDARD_DEVIATION 3.5 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	24.9 kg/m^2 STANDARD_DEVIATION 2.5 • n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Height Part I (SAD)	171.3 cm STANDARD_DEVIATION 13.6 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	169.0 cm STANDARD_DEVIATION 11.0 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	178.0 cm STANDARD_DEVIATION 4.4 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	176.7 cm STANDARD_DEVIATION 13.9 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	176.2 cm STANDARD_DEVIATION 9.6 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	173.3 cm STANDARD_DEVIATION 10.3 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	175.7 cm STANDARD_DEVIATION 10.4 • n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	—	—	—	—	174.1 cm STANDARD_DEVIATION 10.6 • n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Height Part II (MAD)	—	—	—	—	—	—	—	171.0 cm STANDARD_DEVIATION 11.9 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	171.7 cm STANDARD_DEVIATION 8.0 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	172.2 cm STANDARD_DEVIATION 6.8 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	176.0 cm STANDARD_DEVIATION 12.7 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	172.7 cm STANDARD_DEVIATION 9.7 • n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Weight Part I (SAD)	65.7 kg STANDARD_DEVIATION 13.4 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	72.5 kg STANDARD_DEVIATION 16.9 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	79.8 kg STANDARD_DEVIATION 13.3 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	81.0 kg STANDARD_DEVIATION 18.0 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	81.0 kg STANDARD_DEVIATION 11.0 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	66.3 kg STANDARD_DEVIATION 8.2 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	74.7 kg STANDARD_DEVIATION 13.8 • n=12 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	—	—	—	—	74.4 kg STANDARD_DEVIATION 14.5 • n=48 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.
Weight Part II (MAD)	—	—	—	—	—	—	—	76.2 kg STANDARD_DEVIATION 9.0 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	69.8 kg STANDARD_DEVIATION 11.9 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	72.3 kg STANDARD_DEVIATION 5.5 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	81.0 kg STANDARD_DEVIATION 17.2 • n=6 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.	74.8 kg STANDARD_DEVIATION 11.7 • n=24 Participants • The demographics and baseline characteristics for subjects included in the different Part I (SAD) cohorts (dose level 1-300 mg) and Part II (MAD) cohorts (dose levels 20-180 mg) are presented separately since subjects were only included in one cohort.

PRIMARY outcome

Timeframe: AEs were collected from the start of IMP administration until the end-of-study visit of each part, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).