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

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.

Study Overview

• Status: Terminated
• Conditions: Healthy Adult Volunteers
• Intervention / Treatment: Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials Medical Group
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel Baltimore Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel 1: BMS-986090 (0.5 mg) or Placebo; BMS-986090 0.5 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once	Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Experimental: Panel 2: BMS-986090 (3 mg) or Placebo; BMS-986090 3 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once	Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Experimental: Panel 3: BMS-986090 (10 mg) or Placebo; BMS-986090 10 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once	Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Experimental: Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg); 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	Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin; Other Names: KLH
Experimental: Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg); 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	Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin; Other Names: KLH
Experimental: Panel 6: BMS-986090 (100 mg) or Placebo; BMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once	Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Experimental: Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg); 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	Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin; Other Names: KLH
Experimental: Panel 8: BMS-986090 (750 mg) or Placebo; BMS-986090 750 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once	Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Experimental: Panel 9: BMS-986090 (150 mg) or Placebo; 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	Drug: BMS-986090; Drug: Placebo matching with BMS-986090

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Total body clearance (CLT) of single dose BMS-986090 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
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
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
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
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
Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion	Days 1 -85

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Keyhole-limpet hemocyanin
• Other Study ID Numbers: IM142-003