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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

Primary Purpose

Liver Fibrosis/NASH

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986171
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Liver Fibrosis/NASH

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Profil Institute For Clinical Research, Inc.
  • Wcct Global, Llc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: Single Ascending Dose (SAD)

Part B: Multiple Ascending Dose (MAD)

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

Arm Description

BMS-986171 or Placebo on specified days

BMS-986171 or Placebo on specified days

BMS-986171 or Placebo on specified days

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Immunogenicity based on antibody responses

Full Information

First Posted
August 21, 2015
Last Updated
May 22, 2017
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02538874
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 31, 2015 (Actual)
Primary Completion Date
November 4, 2016 (Actual)
Study Completion Date
November 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis/NASH

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Single Ascending Dose (SAD)
Arm Type
Experimental
Arm Description
BMS-986171 or Placebo on specified days
Arm Title
Part B: Multiple Ascending Dose (MAD)
Arm Type
Experimental
Arm Description
BMS-986171 or Placebo on specified days
Arm Title
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)
Arm Type
Experimental
Arm Description
BMS-986171 or Placebo on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986171
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
Adverse Event (AE)
Time Frame
up to 30 days after the last dose
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
Immunogenicity based on antibody responses
Time Frame
6 months following study discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute For Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Wcct Global, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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