A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05546151

Enrollment

Registered

2022-09-19

Start date

2022-09-28

Completion date

2023-04-07

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

BMS-986322, Japanese descent

Brief summary

The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.

Interventions

DRUGBMS-986322

Specified dose on specified days

OTHERPlacebo for BMS-986322

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Participant must be of Japanese descent (both biological parents are ethnically Japanese). * In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations. * Women should be of non-childbearing potential.

Exclusion criteria

* Any significant acute or chronic medical illness. * Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. * Any major surgery within 90 days of study drug administration. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Number of participants with AEs	Up to 7 weeks
Number of participants with serious adverse events (SAEs)	Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation	Up to 7 weeks
Number of deaths	Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities	Up to 7 weeks
Number of participants with vital sign abnormalities	Up to 7 weeks
Number of participants with physical examination abnormalities	Up to 7 weeks
Number of participants with clinical laboratory abnormalities	Up to 7 weeks

Secondary

Measure	Time frame
Time of maximum observed plasma concentration (Tmax)	Day 1 and Day 14
Area under the concentration-time curve within a dosing interval (AUC[TAU])	Day 1 and Day 14
Maximum observed plasma concentration (Cmax)	Day 1 and Day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026