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

NCT ID: NCT05813717

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2023-10-02

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort J1

Group Type EXPERIMENTAL

BMS-986325

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Specified dose on specified days

Cohort J2

Group Type EXPERIMENTAL

BMS-986325

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Specified dose on specified days

Cohort J3

Group Type EXPERIMENTAL

BMS-986325

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986325

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type DRUG

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Cypress, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM039-1001

Identifier Type: -

Identifier Source: org_study_id

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