A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body

Study Overview
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Brief Summary
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The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.

Official Title
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A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects

Conditions
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Liver Fibrosis/NASH

Intervention / Treatment
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* Drug: BMS-986171
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Age 21 to 55 years (Part A,B, and C) BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ [height (m)] Exclusion Criteria: Any significant medical illness Cannot tolerate subcutaneous injections, or having blood samples taken Smoking more than 10 cigarettes/day History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics. HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Single Ascending Dose (SAD)<br>BMS-986171 or Placebo on specified days | Drug: BMS-986171<br> <br> Other: Placebo<br> <br> |
| Experimental: Part B: Multiple Ascending Dose (MAD)<br>BMS-986171 or Placebo on specified days | Drug: BMS-986171<br> <br> Other: Placebo<br> <br> |
| Experimental: Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)<br>BMS-986171 or Placebo on specified days | Drug: BMS-986171<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation | Adverse Event (AE) | up to 30 days after the last dose | 
| Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation |  | up to 30 days after the last dose | 
| Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations |  | up to 30 days after the last dose | 
| Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations |  | up to 30 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity based on antibody responses |  | 6 months following study discharge. |