A Study of Experimental Medication BMS-986036 Given to Healthy Participants

Study Overview
=================
Brief Summary
-----------------
This is a study of experimental medication BMS-986036 given to healthy participants.

Official Title
-----------------
An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants

Conditions
-----------------
Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: BMS-986036


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations BMI of 18 to ≤ 40 kg/m2 Exclusion Criteria: Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds) Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration Known or suspected autoimmune disorder, excluding vitiligo Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status Any significant acute or chronic medical illness Current or recent (within 3 months of study drug administration) gastrointestinal disease Any major surgery within 6 weeks of study drug administration History of diabetes mellitus Other protocol defined inclusion/exclusion criteria could apply

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>BMI 18.0 to ≤ 25.0 | Drug: BMS-986036<br>* Crossover administration to abdomen then upper arm<br>|
| Experimental: Cohort 2<br>BMI >25.0 to ≤ 30.0 | Drug: BMS-986036<br>* Crossover administration to abdomen then upper arm<br>|
| Experimental: Cohort 3<br>BMI >30.0 ≤ 40.0 | Drug: BMS-986036<br>* Crossover administration to abdomen then upper arm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | 29 days | 
| Time of maximum observed serum concentration (Tmax) |  | 29 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)] |  | 29 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)] |  | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of injection site reactions |  | Up to 78 days | 
| Number of adverse events (AE) |  | Up to 78 days | 
| Number of serious adverse events (SAE) |  | Up to 78 days | 
| Number of AEs leading to discontinuation |  | Up to 78 days | 
| Number of deaths |  | Up to 78 days | 
| Serum biomarker antibody concentration |  | Up to 78 days |