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

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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

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

Trial contacts and locations

0

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Central trial contact

First line of email MUST contain NCT # and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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