A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenously Administered BMS-986446 in Healthy Participants Including Healthy Participants of Japanese Ethnicity

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: BMS-986446
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel 2. No limitations on ethnicity apply to Part 2, Panel 1 Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator Body mass index (BMI) of at least 18 kg/m^2 but no more than 32 kg/m^2 at screening Body weight between 45 kg and 110 kg Exclusion Criteria: Any clinically significant deviation from normal, as judged by the investigator Any major surgery within 90 days of study drug administration Participation in another interventional clinical trial concurrent with this study Note: Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986446<br> | Drug: BMS-986446<br>* Specified dose on specified days<br>|
| Experimental: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to Day 85 | 
| Number of participants with vital sign abnormalities |  | Up to Day 85 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to Day 85 | 
| Number of participants with physical examination abnormalities |  | Up to Day 85 | 
| Number of participants with body weight abnormalities |  | Up to Day 85 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to Day 85 | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to Day 85 | 
| Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] |  | Up to Day 85 | 
| Number of participants with anti-drug antibody (ADA) |  | Up to Day 85 | 
| Geometric mean ratios of Cmax |  | Up to Day 85 | 
| Geometric mean ratios of [AUC(0-T)] |  | Up to Day 85 | 
| Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] |  | Up to Day 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Healthy Participants, Healthy Japanese Participants, BMS-986446, PRX005