Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects
Phase 1
Terminated
- Conditions
- Healthy Adult Volunteers
- Interventions
- Registration Number
- NCT02079480
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Healthy male and female (of not childbearing potential), ages 18-45 years, inclusive
- BMI 18 to 32 kg/m2, inclusive
Exclusion Criteria
- Any significant acute or chronic medical illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg) Keyhole limpet hemocyanin BMS-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 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg) Placebo matching with BMS-986090 BMS-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) Placebo matching with BMS-986090 BMS-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 Placebo matching with BMS-986090 BMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once Panel 1: BMS-986090 (0.5 mg) or Placebo Placebo matching with BMS-986090 BMS-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 BMS-986090 BMS-986090 3 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 Placebo matching with BMS-986090 BMS-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 BMS-986090 BMS-986090 10 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 Placebo matching with BMS-986090 BMS-986090 10 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg) Placebo matching with BMS-986090 BMS-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 BMS-986090 BMS-986090 750 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once Panel 8: BMS-986090 (750 mg) or Placebo Placebo matching with BMS-986090 BMS-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 BMS-986090 BMS-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 Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg) BMS-986090 BMS-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 9: BMS-986090 (150 mg) or Placebo Placebo matching with BMS-986090 BMS-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 Panel 6: BMS-986090 (100 mg) or Placebo BMS-986090 BMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once Panel 1: BMS-986090 (0.5 mg) or Placebo BMS-986090 BMS-986090 0.5 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) BMS-986090 BMS-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) BMS-986090 BMS-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 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg) Keyhole limpet hemocyanin BMS-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) Keyhole limpet hemocyanin BMS-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
- Primary Outcome Measures
Name Time Method 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 Up to Day 85 after single dose of BMS-986090 AE = Adverse event
ECG = ElectrocardiogramSafety 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 Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV) Days 1 -85 Cmax accumulation index (AI_Cmax); ratio of Cmax at steady state to Cmax after the first dose of BMS-986090 SC (multiple dose) Days 1 -106 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 Total body clearance (CLT) of single dose BMS-986090 IV Days 1 -85 Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC Days 1 -106 Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC 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 in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC Days 1 -106 Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC Days 1 -106 Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC Days 1 -106 Degree of Fluctuation (DF) of multiple dose BMS-986090 SC Days 1 -106 AUC accumulation index (AI_AUC); ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986090 SC (multiple dose) Days 1 -106 Immunogenicity of BMS-986090 following single SC / IV infusion measured by frequency of subjects with positive anti-drug-antibody (ADA) assessment and frequency of subjects who develop positive ADA following a negative baseline 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 Apparent total body clearance (CLT/F) of single dose BMS-986090 SC Days 1 -85 Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV Days 1 -85 Volume of distribution during steady state (Vss) of single dose BMS-986090 IV Days 1 -85 Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC Days 1 -85 Absolute bioavailability (F) of single dose BMS-986090 SC Days 1 -85 Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC Days 1 -106 Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC Days 1 -106 Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC Days 1 -106 Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion Days 1 -85
Trial Locations
- Locations (2)
Parexel Baltimore Early Phase Clinical Unit
🇺🇸Baltimore, Maryland, United States
California Clinical Trials Medical Group
🇺🇸Glendale, California, United States