Recruiting
Phase 1

BMS-986521

Sponsor:

Bristol-Myers Squibb

Code:

NCT07283263

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

BMS-985521

Placebo

Study Details

Brief summary:

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.

Conditions

Healthy Volunteers

Study ID

NCT07283263

Start date

Dec 23, 2025

Status verified date

Jan, 2026

Completion date

Nov 17, 2026

Anticipated

Primary completion date

Nov 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A Cohort 1

experimental: Part A Cohort 2

experimental: Part A Cohort 3

experimental: Part A Cohort 4

experimental: Part A Cohort 5

experimental: Part A Cohort 6

experimental: Part B Cohort 7

experimental: Part B Cohort 8

experimental: Part B Cohort 9

experimental: Part B Cohort 10

experimental: Part B Cohort 11

experimental: Part C

Interventions

BMS-985521

Specified dose on specified days.

Placebo

Specified dose on specified days

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: Up to approximately Day 40 ]
  • Number of participants with treatment-emergent serious adverse events (SAEs) [ Time Frame: 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) [ Time Frame: Up to approximately Day 14 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

Recruiting

Anaheim, California, United States, 92801

Contacts

Peter Winkle, Site 0001

949-295-7809

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Healthy Volunteers
  • Pharmacokinetics
  • BMS-986521
  • Placebo
  • Drug-food Interaction
  • Single Ascending Dose (SAD)
  • Multiple Ascending Dose (MAD)
  • Elderly
  • Relative Bioavailability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-01-07.