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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: BMS-986325

Study type: Interventional

Funder types: Industry

Identifiers

NCT05813717

IM039-1001

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups

Cohort J1

Experimental group

Treatment:

Drug: BMS-986325

Drug: Placebo

Cohort J2

Experimental group

Treatment:

Drug: BMS-986325

Drug: Placebo

Cohort J3

Experimental group

Treatment:

Drug: BMS-986325

Drug: Placebo