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A Study of BMS-986521 in Healthy Volunteers

This study is looking for healthy adults to help evaluate a new drug called BMS-986521. Researchers want to understand how safe BMS-986521 is, how well your body tolerates it, and how much of the drug stays in your system. You might receive BMS-986521 or a placebo (an inactive substance, like a sugar pill). The study will also look at how food might affect the drug. To join, you must be between 18 and 80 years old, healthy, and meet specific weight and health criteria. The main goals are to track any side effects and serious side effects, and to monitor for any thoughts of self-harm, for up to about 40 days.

Study design
This is an interventional study involving 106 healthy participants. Participants will receive either BMS-986521 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately 40 days after treatment, and for suicidal thoughts and behavior for up to about 14 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07283263

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Bristol-Myers Squibb
~106 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:BMS-985521Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (AEs)
Measured over Up to approximately Day 40
+2 more outcomes measured

Conditions

Healthy Volunteers

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Healthy Volunteers

NCT07283263

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

    Anaheim, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with treatment-emergent adverse events (AEs)Up to approximately Day 40
  • Number of participants with treatment-emergent serious adverse events (SAEs)Up to approximately Day 40
  • Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)Up to approximately Day 14