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

NCT ID: NCT02538874

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-11-05

Brief Summary

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The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.

Detailed Description

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Conditions

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Liver Fibrosis/NASH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose (SAD)

BMS-986171 or Placebo on specified days

Group Type EXPERIMENTAL

BMS-986171

Intervention Type DRUG

Placebo

Intervention Type OTHER

Part B: Multiple Ascending Dose (MAD)

BMS-986171 or Placebo on specified days

Group Type EXPERIMENTAL

BMS-986171

Intervention Type DRUG

Placebo

Intervention Type OTHER

Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)

BMS-986171 or Placebo on specified days

Group Type EXPERIMENTAL

BMS-986171

Intervention Type DRUG

Placebo

Intervention Type OTHER

Interventions

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BMS-986171

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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 illness
* Cannot tolerate subcutaneous injections, or having blood samples taken
* Smoking more than 10 cigarettes/day
* History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
* HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
* Pregnancy
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Profil Institute For Clinical Research, Inc.

Chula Vista, California, United States

Site Status

Wcct Global, Llc

Cypress, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MB007-005

Identifier Type: -

Identifier Source: org_study_id

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