A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986325
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be ethnically Japanese (both biological parents are ethnically Japanese). Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening. Exclusion Criteria: Any significant acute or chronic medical illness. Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy). Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort J1<br> | Drug: BMS-986325<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Cohort J2<br> | Drug: BMS-986325<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Cohort J3<br> | Drug: BMS-986325<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse events |  | Up to day 92 | 
| Number of participants with clinical laboratory abnormalities |  | Up to day 64 | 
| Number of participants with vital sign abnormalities |  | Up to day 64 | 
| Number of participants with ECG abnormalities |  | Up to day 64 | 
| Number of participants with physical examination abnormalities |  | Up to day 64 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of BMS-986325 |  | Up to day 64 | 
| Maximum observed serum concentration (Cmax) |  | Up to day 64 | 
| Time of maximum observed serum concentration (Tmax) |  | Up to day 64 | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) |  | Up to day 64 | 
| Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation | Receptor occupancy assays are measured by BMS-986325 binding with fluorescently conjugated antibodies on B cells. Receptor occupancy is calculated as a ratio of fluorescence intensity using unchallenged samples over fluorescence intensity using saturated samples. | Up to day 64 | 
| Absolute Bioavailability (F) of BMS-986325 | Measured as a percentage | Up to day 64 | 
| Number of Participants With Anti-Drug Antibody Response |  | Up to day 64 |