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

A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02538874

Enrollment

275

Registered

2015-09-02

Start date

2015-10-31

Completion date

2016-11-05

Last updated

2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis/NASH

Brief summary

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.

Interventions

DRUGBMS-986171

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Immunogenicity based on antibody responses	6 months following study discharge.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026