A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 275
- Locations
- 2
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Part A: Single Ascending Dose (SAD)
BMS-986171 or Placebo on specified days
Intervention: BMS-986171 (Drug)
Part A: Single Ascending Dose (SAD)
BMS-986171 or Placebo on specified days
Intervention: Placebo (Other)
Part B: Multiple Ascending Dose (MAD)
BMS-986171 or Placebo on specified days
Intervention: BMS-986171 (Drug)
Part B: Multiple Ascending Dose (MAD)
BMS-986171 or Placebo on specified days
Intervention: Placebo (Other)
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)
BMS-986171 or Placebo on specified days
Intervention: BMS-986171 (Drug)
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)
BMS-986171 or Placebo on specified days
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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)
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
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
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
- Immunogenicity based on antibody responses(6 months following study discharge.)