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

NCT ID: NCT06084598

Last Updated: 2024-03-15

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2024-03-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BMS-986446

Group Type EXPERIMENTAL

BMS-986446

Intervention Type DRUG

Specified dose on specified days

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986446

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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CN008-0016

Identifier Type: -

Identifier Source: org_study_id

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