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BMS-986447

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Apr 5, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986447 · 1 trial · 1 indication

Phase 1 1
NCT05760937A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy ParticipantsHealthy Participants
COMPLETED32 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AEs)
Up to 59 days
Number of Participants with Serious AEs (SAEs)
Up to 59 days
Number of Participants with Clinical Laboratory Abnormalities
Up to 34 days
Number of Participants with Vital Sign Abnormalities
Up to 35 days
Number of Participants with Physical Examination Abnormalities
Up to 35 days
Number of Participants with Electrocardiogram (ECG) Abnormalities
Up to 34 days

Secondary Endpoints

Maximum observed plasma concentration (Cmax)
Up to 72 hours postdose
Time of maximum observed plasma concentration (Tmax)
Up to 72 hours postdose
Apparent terminal phase half-life (T-Half)
Up to 72 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986447EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-986447DRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index between 18 and 30 kilograms per metered square (kg/m\^2), inclusive. * Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations. * A negative ...

Countries:United States
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Frequently asked questions about BMS-986447

What is BMS-986447 used for?

BMS-986447 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with the goal of evaluating its safety, tolerability, and drug levels. It is not approved for any indication and remains in early-stage clinical testing.

Who makes BMS-986447?

BMS-986447 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 clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational small molecule in healthy participants.

What phase is BMS-986447 in?

BMS-986447 is in Phase 1 clinical development. The Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy are still being evaluated in early-stage studies.

What clinical trials is BMS-986447 in?

BMS-986447 has one completed Phase 1 clinical trial, identified as NCT05760937. This study evaluated the safety, tolerability, and drug levels of BMS-986447 in healthy participants. The trial was conducted in the United States, enrolled 32 participants, and was randomized, double-blind, and placebo-controlled.

Is BMS-986447 FDA approved?

BMS-986447 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on healthy participants to assess safety, tolerability, and drug levels. Further clinical studies are required before any regulatory approval can be considered.