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Completed

NCT Number: NCT02538874

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

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.

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Key information

Conditions

Liver Fibrosis/NASH

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institute For Clinical Research, Inc., Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986171

Drug

Placebo

Other

Primary outcomes

  1. 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

    Time frame: up to 30 days after the last dose

    Adverse Event (AE)

  2. 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

    Time frame: up to 30 days after the last dose

  3. 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

    Time frame: up to 30 days after the last dose

  4. 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

    Time frame: up to 30 days after the last dose

Secondary outcomes

  1. Immunogenicity based on antibody responses

    Time frame: 6 months following study discharge.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2015
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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