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BMS-986171

Phase 1

Liver Fibrosis/NASH | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: May 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment275

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986171 · 1 trial · 1 indication

Phase 1 1
NCT02538874A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the BodyLiver Fibrosis/NASH
COMPLETED275 Analytics
PHASE1COMPLETED
A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body
Liver Fibrosis/NASH
NCT02538874275
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Study Endpoints

Primary Endpoints

Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
up to 30 days after the last dose

Adverse Event (AE)

Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
up to 30 days after the last dose
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
up to 30 days after the last dose
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
up to 30 days after the last dose

Secondary Endpoints

Immunogenicity based on antibody responses
6 months following study discharge.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: Single Ascending Dose (SAD)EXPERIMENTALBMS-986171 or Placebo on specified days
Part B: Multiple Ascending Dose (MAD)EXPERIMENTALBMS-986171 or Placebo on specified days
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)EXPERIMENTALBMS-986171 or Placebo on specified days

Interventions

NameTypeDescription
BMS-986171DRUG -
PlaceboOTHER -
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Age 21 to 55 years (Part A,B, and C) * BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ \[height (m)\] Exclusion Criteria: * Any significant medical ill...

Countries:United States
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Frequently asked questions about BMS-986171

What is BMS-986171 used for?

BMS-986171 is an investigational small molecule being developed for the treatment of liver fibrosis and nonalcoholic steatohepatitis (NASH). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BMS-986171?

BMS-986171 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is BMS-986171 in?

BMS-986171 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is BMS-986171 in?

BMS-986171 has one completed Phase 1 clinical trial, identified as NCT02538874. This study enrolled 275 healthy volunteers in the United States to assess the drug's safety, blood levels, and effects on the body.

Is BMS-986171 the same as any other drug?

No alternative names for BMS-986171 have been disclosed. It is identified solely by its development code BMS-986171 and is not known to be marketed under any other name.