Recent Updates
Recently added Catalysts

BMS-985521

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 7, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

BMS-985521 · 1 trial · 1 indication

Phase 1 1
NCT07283263A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.Healthy Volunteers
RECRUITING106 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Maximum Concentration (Cmax) of BMS-986521 in Plasma
Up to approximately Day 14
Time to Cmax (Tmax) of BMS-986521 in Plasma
Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma
Up to approximately Day 14
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A Cohort 1EXPERIMENTAL -
Part A Cohort 2EXPERIMENTAL -
Part A Cohort 3EXPERIMENTAL -
Part A Cohort 4EXPERIMENTAL -
Part A Cohort 5EXPERIMENTAL -
Part A Cohort 6EXPERIMENTAL -
Part B Cohort 7EXPERIMENTAL -
Part B Cohort 8EXPERIMENTAL -
Part B Cohort 9EXPERIMENTAL -
Part B Cohort 10EXPERIMENTAL -
Part B Cohort 11EXPERIMENTAL -
Part CEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-985521DRUGSpecified dose on specified days.
PlaceboOTHERSpecified dose on specified days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about BMS-985521

What is BMS-985521 used for?

BMS-985521 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development to evaluate its safety, tolerability, and drug levels in the body. The drug is not approved for any medical condition and is still in early-stage clinical testing.

Who makes BMS-985521?

BMS-985521 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting a Phase 1 clinical trial to assess the drug's safety and pharmacokinetics in healthy participants.

What phase is BMS-985521 in?

BMS-985521 is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers to evaluate its safety, tolerability, and drug levels. The drug is not FDA approved and remains in early-stage clinical testing.

What clinical trials is BMS-985521 in?

BMS-985521 is being studied in a Phase 1 clinical trial with the identifier NCT07283263. This trial is recruiting 106 healthy participants in the United States and is designed to evaluate the safety, tolerability, and drug levels of BMS-985521. The study is randomized, double-blind, and controlled.

Is BMS-985521 the same as BMS-986521?

BMS-985521 and BMS-986521 are different drug names. The clinical trial NCT07283263 is titled 'A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants,' which suggests the drug being studied is BMS-986521, not BMS-985521. The two names are not interchangeable.