Skip to main content
OpenTrials
Completed

NCT Number: NCT05813717

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986325

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with Adverse events

    Time frame: Up to day 92

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Up to day 64

  3. Number of participants with vital sign abnormalities

    Time frame: Up to day 64

  4. Number of participants with ECG abnormalities

    Time frame: Up to day 64

  5. Number of participants with physical examination abnormalities

    Time frame: Up to day 64

Secondary outcomes

  1. Serum concentrations of BMS-986325

    Time frame: Up to day 64

  2. Maximum observed serum concentration (Cmax)

    Time frame: Up to day 64

  3. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to day 64

  4. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to day 64

  5. Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation

    Time frame: Up to day 64

    Receptor occupancy assays are measured by BMS-986325 binding with fluorescently conjugated antibodies on B cells. Receptor occupancy is calculated as a ratio of fluorescence intensity using unchallenged samples over fluorescence intensity using saturated samples.

  6. Absolute Bioavailability (F) of BMS-986325

    Time frame: Up to day 64

    Measured as a percentage

  7. Number of Participants With Anti-Drug Antibody Response

    Time frame: Up to day 64

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.