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BMS-986325

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 7, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986325 · 1 trial · 1 indication

Phase 1 1
NCT05813717A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese ParticipantsHealthy Volunteers
COMPLETED25 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
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Study Endpoints

Primary Endpoints

Number of participants with Adverse events
Up to day 92
Number of participants with clinical laboratory abnormalities
Up to day 64
Number of participants with vital sign abnormalities
Up to day 64
Number of participants with ECG abnormalities
Up to day 64
Number of participants with physical examination abnormalities
Up to day 64

Secondary Endpoints

Serum concentrations of BMS-986325
Up to day 64
Maximum observed serum concentration (Cmax)
Up to day 64
Time of maximum observed serum concentration (Tmax)
Up to day 64
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort J1EXPERIMENTAL -
Cohort J2EXPERIMENTAL -
Cohort J3EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986325DRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be ethnically Japanese (both biological parents are ethnically Japanese). * Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory de...

Countries:United States
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Frequently asked questions about BMS-986325

What is BMS-986325 used for?

BMS-986325 is an investigational small molecule being studied in healthy volunteers. It is being evaluated for safety, tolerability, drug levels, and drug effects in a Phase 1 clinical trial. The drug is not approved for any indication and is still in early clinical development.

Who makes BMS-986325?

BMS-986325 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-986325 in?

BMS-986325 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is completed and was designed to assess safety, tolerability, drug levels, and drug effects in healthy volunteers.

What clinical trials is BMS-986325 in?

BMS-986325 has one completed clinical trial, NCT05813717, which evaluated the safety, tolerability, drug levels, and drug effects of the drug in healthy Japanese participants. The trial enrolled 25 participants and was conducted in the United States.

Is BMS-986325 FDA approved?

BMS-986325 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on healthy volunteers to assess safety and tolerability, and the drug has not yet progressed to later-stage trials or regulatory review.