Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects
Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986090 in Healthy Subjects
1 other identifier
interventional
130
1 country
2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 12, 2016
May 1, 2016
1.9 years
March 4, 2014
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of single dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
AE = Adverse event ECG = Electrocardiogram
Up to Day 85 after single dose of BMS-986090
Safety and tolerability of multiple dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
Up to Day 106 after multiple dose of BMS-986090
Secondary Outcomes (24)
Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV)
Days 1 -85
Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV
Days 1 -85
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of single dose BMS-986090 SC and IV
Days 1 -85
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose BMS-986090 SC and IV
Days 1 -85
Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV
Days 1 -85
- +19 more secondary outcomes
Study Arms (9)
Panel 1: BMS-986090 (0.5 mg) or Placebo
EXPERIMENTALBMS-986090 0.5 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once
Panel 2: BMS-986090 (3 mg) or Placebo
EXPERIMENTALBMS-986090 3 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once
Panel 3: BMS-986090 (10 mg) or Placebo
EXPERIMENTALBMS-986090 10 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once
Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg)
EXPERIMENTALBMS-986090 30 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once And Keyhole limpet hemocyanin (KLH) 1 mg solution single intramuscular dose once
Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg)
EXPERIMENTALBMS-986090 100 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once And KLH 1 mg solution single intramuscular dose once
Panel 6: BMS-986090 (100 mg) or Placebo
EXPERIMENTALBMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once
Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg)
EXPERIMENTALBMS-986090 300 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once And KLH 1 mg solution single intramuscular dose once
Panel 8: BMS-986090 (750 mg) or Placebo
EXPERIMENTALBMS-986090 750 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once
Panel 9: BMS-986090 (150 mg) or Placebo
EXPERIMENTALBMS-986090 150 mg solution subcutaneously once weekly for 4 weeks OR Placebo matching with BMS-986090 0 mg solution subcutaneously once weekly for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female (of not childbearing potential), ages 18-45 years, inclusive
- BMI 18 to 32 kg/m2, inclusive
You may not qualify if:
- \- Any significant acute or chronic medical illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 5, 2014
Study Start
May 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 12, 2016
Record last verified: 2016-05