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A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

RecruitingPhase 1Healthy volunteers welcome

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants

Who can join

Ages 18 to 80 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
* Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
* For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.

Exclusion Criteria:

* Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
* Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
* Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
* Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
* Other protocol defined inclusion/exclusion criteria apply.

About the study

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 106 · Started: Dec 23, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07283263

Locations in the U.S.

CaliforniaCenExel ACT (Formerly Anaheim Clinical Trials; LLC), Anaheim

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.