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BMS-986331

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 20, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986331 · 1 trial · 1 indication

Phase 1 1
NCT04444050Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy ParticipantsHealthy Participants
COMPLETED48 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 13 months
Number of participants with clinical laboratory abnormalities
Up to 46 days
Number of participants with vital sign abnormalities
Up to 46 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 46 days

Secondary Endpoints

Maximum plasma concentration (Cmax)
Up to 17 days
Time to reach Cmax in plasma (Tmax)
Up to 17 days
Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]
Up to 17 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part 1 Single Ascending Dose (SAD): Panel 1EXPERIMENTAL -
Part 1 SAD: Panel 2EXPERIMENTAL -
Part 1 SAD: Panel 3EXPERIMENTAL -
Part 1 SAD: Panel 4EXPERIMENTAL -
Part 1 SAD: Panel 5EXPERIMENTAL -
Part 1 SAD: Panel 6EXPERIMENTAL -
Part 1 SAD: Optional Split-dose PanelEXPERIMENTAL -
Part 2 Multiple Ascending Dose (MAD): Panel 1EXPERIMENTAL -
Part 2 MAD: Panel 2EXPERIMENTAL -
Part 2 MAD: Panel 3EXPERIMENTAL -
Part 2 MAD: Panel 4EXPERIMENTAL -
Part 2 MAD: Optional (to be determined) PanelEXPERIMENTAL -
Part 3 MAD in Japanese Participants (J-MAD): Panel 1EXPERIMENTAL -
Part 3 J-MAD: Panel 2EXPERIMENTAL -
Part 3 J-MAD: Panel 3EXPERIMENTAL -
Part 3 J-MAD: Optional (to be determined) PanelEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986331DRUGSpecified dose on specified days
Placebo, Matching BMS-986331OTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations * A body mass index of 18 - 32 kg/m2, inclusive * Women and men must agree to follow specific methods of contraception, if applicable For J...

Countries:United States
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Frequently asked questions about BMS-986331

What is BMS-986331 used for?

BMS-986331 is an investigational small molecule being studied in healthy participants. It is being evaluated for safety, tolerability, drug levels, and drug effects. The drug is in Phase 1 clinical development and is not approved for any use.

Who makes BMS-986331?

BMS-986331 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants.

What phase is BMS-986331 in?

BMS-986331 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results not yet publicly reported.

What clinical trials is BMS-986331 in?

BMS-986331 has one completed Phase 1 trial, NCT04444050, which evaluated the safety, tolerability, drug levels, and drug effects of the drug in healthy participants. The trial enrolled 48 participants in the United States and was randomized, double-blind, and controlled.

Is BMS-986331 FDA approved?

BMS-986331 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy participants was designed to assess safety and tolerability, but the drug has not been approved for any medical use.