Trial Outcomes & Findings for A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis (NCT NCT03329885)

NCT ID: NCT03329885

Last Updated: 2019-10-21

Results Overview

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with the treatment. A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)
• Results posted on: 2019-10-21

Participant Flow

96 participants were enrolled (screened) of whom 36 were screen failures, 22 were approved but not dosed and 38 were randomized in the study.

Participant milestones

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part C: Multiple Dosing in Psoriasis Patients Psoriasis patients to receive daily escalating oral doses of BMS-986251 or placebo
Overall Study STARTED	9	6	6	6	6	3	1	1	0
Overall Study COMPLETED	9	6	6	6	6	3	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	1	0

Reasons for withdrawal

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part C: Multiple Dosing in Psoriasis Patients Psoriasis patients to receive daily escalating oral doses of BMS-986251 or placebo
Overall Study Sponsor discontinued the study early	0	0	0	0	0	0	1	1	0

Baseline Characteristics

A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

Baseline characteristics by cohort

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Total n=36 Participants Total of all reporting groups
Age, Continuous	30.9 Years STANDARD_DEVIATION 10.46 • n=5 Participants	34.5 Years STANDARD_DEVIATION 7.96 • n=7 Participants	32.3 Years STANDARD_DEVIATION 11.64 • n=5 Participants	37.2 Years STANDARD_DEVIATION 12.26 • n=4 Participants	33.8 Years STANDARD_DEVIATION 12.52 • n=21 Participants	29.0 Years STANDARD_DEVIATION 6.56 • n=10 Participants	33.1 Years STANDARD_DEVIATION 10.28 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	18 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	18 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=10 Participants	35 Participants n=115 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=10 Participants	30 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (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

PRIMARY outcome

Timeframe: AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)

Population: All participants who had received at least one dose of BMS-986251 or placebo.

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with the treatment. A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation % of participants that experienced SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation % of participants that died	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation % of participants with AE leading to study discon.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9 and 11; Part B: Days 1, 2-13, 15, 16, 18, 20, 24

Population: All participants who had received at least one dose of BMS-986251 or placebo.

Vital signs (Systolic and diastolic blood pressure and pulse) were recorded after the participant had been resting for at least 5 minutes in the supine position.

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Number of Participants With Potentially Clinically Significant Changes in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3,5, 7 and 11; Part B: Days 1, 2, 4, 6, 8, 10, and 12,24

Population: All participants who had received at least one dose of BMS-986251 or placebo.

The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTcinterval, (Fridericia's) and the interpretation of the ECG profile by the Investigator

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: Days 2, 4, 7 and 11; Part B: Days 3, 7, 10, 14, 16, 24

Population: All participants who had received at least one dose of BMS-986251 or placebo.

Hematology: Hemoglobin, Hematocrit, Total leukocyte count, including differential Platelet count, Red blood cell count, Reticulocyte count; Chemistry:

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Direct bilirubin, Alkaline phosphatase, Lactate dehydrogenase , (LDH), Creatinine, Urea, Uric acid, Fasting glucose, High sensitivity C-reactive protein (hs-CRP), Total protein, Albumin Sodium, Potassium, Chloride, Calcium Inorganic phosphate, Magnesium, Creatine kinase, Creatinine clearance (CLcr)- screening only, Cholesterol Triglycerides, High-density lipoprotein (HDL), Low-density lipoprotein (LDL), Urinalysis: Protein, Glucose, Blood Leukocyte esterase, Specific gravity, pH,Microscopic examination of the sediment if blood, protein or leukocytes esterase are positive on the dipstick; Other Analyses: Urine test for alcohol, Urine test for drugs of abuse, Pregnancy test

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Parameters	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Maximum Observed Plasma Concentration (Cmax)	—	74.3 ng/mL Standard Deviation 5.88	206 ng/mL Standard Deviation 55.8	659 ng/mL Standard Deviation 207	1131 ng/mL Standard Deviation 278	2147 ng/mL Standard Deviation 175	—	NA ng/mL Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Time of Maximum Observed Plasma Concentration (Tmax)	—	3.50 h Interval 1.5 to 6.0	2.27 h Interval 1.02 to 4.02	1.53 h Interval 1.02 to 8.0	2.53 h Interval 2.02 to 4.02	1.05 h Interval 1.02 to 1.07	—	NA h Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)]	—	5530 ng.h/mL Standard Deviation 954	14737 ng.h/mL Standard Deviation 3339	36318 ng.h/mL Standard Deviation 9554	71172 ng.h/mL Standard Deviation 13328	126198 ng.h/mL Standard Deviation 21811	—	NA ng.h/mL Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] (Part A)	—	6052 ng.h/mL Standard Deviation 1221	15815 ng.h/mL Standard Deviation 3926	38080 ng.h/mL Standard Deviation 10827	75335 ng.h/mL Standard Deviation 14726	130873 ng.h/mL Standard Deviation 24294	—	—

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Terminal Elimination Half-life, Calculated as 0.693/Kel [t(1/2)]	—	70.9 h Standard Deviation 16.5	62.6 h Standard Deviation 15.0	52.2 h Standard Deviation 9.02	54.6 h Standard Deviation 13.6	48.2 h Standard Deviation 7.02	—	NA h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Day 1, Part B: Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Apparent (Oral) Clearance (CL/F) Calculated as Dose/[AUC(0-inf)] for Single Dose	—	0.343 L/h Standard Deviation 0.076	0.400 L/h Standard Deviation 0.100	0.419 L/h Standard Deviation 0.109	0.411 L/h Standard Deviation 0.078	0.469 L/h Standard Deviation 0.083	—	NA L/h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Apparent Volume of Distribution at Terminal Phase [V(z)/F]	—	34.1 L Standard Deviation 6.39	35.3 L Standard Deviation 8.52	30.6 L Standard Deviation 5.54	32.3 L Standard Deviation 9.44	32.1 L Standard Deviation 3.98	—	NA L Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Cumulative Urinary Excretion (of the Unchanged Drug) [Ae(t)]	—	0 mg Standard Deviation 0	0 mg Standard Deviation 0	0.002 mg Standard Deviation 0.002	0.009 mg Standard Deviation 0.002	0.020 mg Standard Deviation 0.011	—	NA mg Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Amount Excreted Unchanged in Urine (% of Dose) [Fe(Urine)%]	—	0 Percentage of dose Standard Deviation 0	0 Percentage of dose Standard Deviation 0	0.012 Percentage of dose Standard Deviation 0.011	0.031 Percentage of dose Standard Deviation 0.007	0.033 Percentage of dose Standard Deviation 0.018	—	NA Percentage of dose Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Renal Clearance [CL(R)]	—	0 L/h Standard Deviation 0	0 L/h Standard Deviation 0	0.00005 L/h Standard Deviation 0.00004	0.00016 L/h Standard Deviation 0.00006	0.00019 L/h Standard Deviation 0.00012	—	NA L/h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

PRIMARY outcome

Timeframe: Part B : Days 1 and Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Area Under the Concentration-time Curve Over 24 Hours (One Dosing Interval) [AUC(0-24)] (Part B)	—	NA ng.h/mL Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Ratio of AUC(0-24) Following Last Dose to AUC(0-24) Following First Dose [AR[AUC(0-24)]] (Part B)	—	NA Ratio Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part B : Day 14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Ratio of Cmax Following Last Dose to Cmax Following First Dose [AR(Cmax)] (Part B)	—	NA Ratio Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part B : Days 2-14

Population: All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Outcome measures

Measure	Part A: Placebo Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Pre-dose Plasma Concentration (Cpre) (Part B)	—	NA ng/mL Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part B : Days 16, 20, and 24

Population: All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Outcome measures

Measure	Part A: Placebo n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Inhibition at Time t [I(t)] (Part B)	NA Percent inhibition Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	NA Percent inhibition Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

Population: All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Maximum Observed Inhibition [I(Max)]	27.0 Percent inhibition Standard Deviation 24.0	36.9 Percent inhibition Standard Deviation 9.54	44.2 Percent inhibition Standard Deviation 8.89	58.2 Percent inhibition Standard Deviation 4.18	72.7 Percent inhibition Standard Deviation 11.3	73.9 Percent inhibition Standard Deviation 10.9	NA Percent inhibition Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	NA Percent inhibition Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

SECONDARY outcome

Timeframe: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

Population: All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Time of Maximum Observed Inhibition [t(Imax)]	2.00 h Interval 1.0 to 240.0	1.00 h Interval 1.0 to 24.0	13.00 h Interval 1.0 to 240.0	1.00 h Interval 1.0 to 48.0	1.00 h Interval 1.0 to 24.0	2.00 h Interval 1.0 to 4.0	NA h Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	NA h Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

SECONDARY outcome

Timeframe: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

Population: All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Time of Inhibition Above 50% [t(I>50%)]	NA h Standard Deviation NA Inhibition\>50% showed an intermittent pattern (above and below 50%) over time. Due to the variation over time it was not possible to calculate a reliable \[t (I\>50%)	NA h Standard Deviation NA Inhibition\>50% showed an intermittent pattern (above and below 50%) over time. Due to the variation over time it was not possible to calculate a reliable \[t (I\>50%)	NA h Standard Deviation NA Inhibition\>50% showed an intermittent pattern (above and below 50%) over time. Due to the variation over time it was not possible to calculate a reliable \[t (I\>50%)	NA h Standard Deviation NA Inhibition\>50% showed an intermittent pattern (above and below 50%) over time. Due to the variation over time it was not possible to calculate a reliable \[t (I\>50%)	NA h Standard Deviation NA Inhibition\>50% showed an intermittent pattern (above and below 50%) over time. Due to the variation over time it was not possible to calculate a reliable \[t (I\>50%)	NA h Standard Deviation NA Inhibition\>50% showed an intermittent pattern (above and below 50%) over time. Due to the variation over time it was not possible to calculate a reliable \[t (I\>50%)	NA h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	NA h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

SECONDARY outcome

Timeframe: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

Population: All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Outcome measures

Measure	Part A: Placebo n=9 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 Participants Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Time of Inhibition Above 90% [t(I>90%)]	NA h Standard Deviation NA Data did not allow for these calculations	NA h Standard Deviation NA Data did not allow for these calculations	NA h Standard Deviation NA Data did not allow for these calculations	NA h Standard Deviation NA Data did not allow for these calculations	NA h Standard Deviation NA Data did not allow for these calculations	NA h Standard Deviation NA Data did not allow for these calculations	NA h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	NA h Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality

SECONDARY outcome

Timeframe: Part B : Days 2, 4, 7, and 14

Population: All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Outcome measures

Measure	Part A: Placebo n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=1 Participants Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Pre-dose Inhibition [I(Pre)] (Part B)	NA Percent inhibition Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	NA Percent inhibition Standard Deviation NA Due to the early termination of the study, only one subject was exposed to multiple doses of BMS-986251 in Part B.Individual data not presented to maintain confidentiality	—	—	—	—	—	—

Adverse Events

Part A: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: BMS-986251 2 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A: BMS-986251 6 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A: BMS-986251 15 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: BMS-986251 30 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A : BMS-986251 60 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B: 3 mg QD (Once Daily)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part A: Placebo n=9 participants at risk Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 2 mg n=6 participants at risk Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 6 mg n=6 participants at risk Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 15 mg n=6 participants at risk Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A: BMS-986251 30 mg n=6 participants at risk Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part A : BMS-986251 60 mg n=3 participants at risk Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	Part B: Placebo n=1 participants at risk Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	Part B: 3 mg QD (Once Daily) n=1 participants at risk Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
Gastrointestinal disorders Abdominal Discomfort	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Abdominal Distension	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 2/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Dry Mouth	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 2/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Vomiting	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Flatulence	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Food Poisoning	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Haematochezia	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Nausea	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Gastrointestinal disorders Proctalgia	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
General disorders Fatigue	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 2/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
General disorders Vessel Puncture Site Reaction	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 1/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
General disorders Catheter Site Haematoma	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 1/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
General disorders Catheter Site Related Reaction	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
General disorders Complication Associated With Device	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
General disorders Medical Device Site Reaction	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Infections and infestations Nasopharyngitis	22.2% 2/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Musculoskeletal and connective tissue disorders Back Pain	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Nervous system disorders Headache	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 2/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	50.0% 3/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Nervous system disorders Dizziness	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Nervous system disorders Poor Quality Sleep	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 1/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Psychiatric disorders Anxiety	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Skin and subcutaneous tissue disorders Acne	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	33.3% 1/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Skin and subcutaneous tissue disorders Blister	11.1% 1/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/9 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	16.7% 1/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/6 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/3 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)	0.00% 0/1 • AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B) (Approximately 9 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: clinical.trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60