The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
130
California Clinical Trials Medical Group
Glendale, California, United States
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States
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
Time frame: 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
Time frame: Up to Day 106 after multiple dose of BMS-986090
Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV)
Time frame: Days 1 -85
Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV
Time frame: 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
Time frame: 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
Time frame: Days 1 -85
Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV
Time frame: Days 1 -85
Total body clearance (CLT) of single dose BMS-986090 IV
Time frame: Days 1 -85
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Apparent total body clearance (CLT/F) of single dose BMS-986090 SC
Time frame: Days 1 -85
Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV
Time frame: Days 1 -85
Volume of distribution during steady state (Vss) of single dose BMS-986090 IV
Time frame: Days 1 -85
Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC
Time frame: Days 1 -85
Absolute bioavailability (F) of single dose BMS-986090 SC
Time frame: Days 1 -85
Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Area under the serum concentration-time curve in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Degree of Fluctuation (DF) of multiple dose BMS-986090 SC
Time frame: 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)
Time frame: 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)
Time frame: Days 1 -106
Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC
Time frame: 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
Time frame: Days 1 -85
Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion
Time frame: Days 1 -85