Safety and drug levels of BMS-986521 in healthy adults
Official title: 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
Run by Bristol-Myers Squibb · NCT07283263 · Data updated 2026-11-12
This trial will test how safe and tolerable BMS-986521 is in healthy adults, measure drug levels after single and multiple doses, and see if food affects those levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Anaheim, California) |
| Status | Recruiting |
| Started | December 23, 2025 |
| Main results expected | November 17, 2026 |
| Study ends | November 17, 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07283263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults who are not of childbearing potential, weigh at least 50 kg, have a BMI between 18 and 32 kg/m², and have no clinically significant medical abnormalities are ideal candidates, with limited inclusion of stable cardiovascular conditions in a specified cohort.
✕Probably not a fit
People with significant medical conditions, a history of rhabdomyolysis or certain cancers, those of childbearing potential, or anyone seeking direct therapeutic benefit should not expect clinical benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial enrolls healthy adult volunteers to receive single and multiple ascending doses of BMS-986521 or placebo to determine safety, tolerability, and pharmacokinetics. Participants must pass screening including medical history, physical exam, ECG, and laboratory tests and meet BMI and weight requirements. Specific cohorts will examine potential food effects on drug exposure and one cohort may include participants with stable cardiovascular conditions if suitable. Dosing and monitoring occur at a single clinical research site in Anaheim, California.
Why it matters
Potential benefit: If successful, this work could provide early safety and dosing information that helps guide later studies which may lead to effective treatments for patients.
How similar studies have gone: This is a standard healthy-volunteer Phase 1 safety and pharmacokinetic design that has been used successfully to establish dosing for many investigational drugs, although outcomes for BMS-986521 itself are not yet known.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.