To obtain safety and tolerability information in healthy subjects is administered as a single dose
* Study Classification: Pharmacokinetics and Pharmacodynamics * Intervention Model: Single Ascending Dose (SAD) study * Allocation: Randomized Non-Stratified
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Metabolic And Atherosclerosis Research Center/ Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs
Time frame: Up to Day 43
Pharmacodynamic effects of single subcutaneous (SC) and intravenous (IV) doses of BMS-962476
Pharmacodynamic effects will be measured by fasting lipid panel
Time frame: Up to Day 43
Maximum observed plasma concentration (Cmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Time of maximum observed plasma concentration (Tmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC(0-T)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Plasma elimination half-life (T-HALF) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
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Total body clearance (CL/F) of BMS-962476 SC Dosing
Time frame: 15 time points up to Day 43
Total body clearance (CL) of BMS-962476 IV Dosing
Time frame: 17 time points up to Day 43
Volume of distribution at steady state (Vss/F) of BMS-962476 SC Dosing
Time frame: 15 time points up to Day 43
Volume of distribution at steady state (Vss) of BMS-962476 IV Dosing
Time frame: 15 time points up to Day 43
Absolute bioavailability (F) of total and free BMS-962476
Time frame: 15 time points up to Day 43
Frequency of anti-BMS-962476 antibodies (immunogenicity) following single SC and IV doses of BMS-962476
Time frame: Up to Day 43