Recruitment Complete
Sponsor ID
20250012
Comparing the Extent to Which Two Evolocumab Drug Products are Made Available in the Body after a Single Subcutaneous Dose.
Study Details
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Protocol Summary
Primary Outcome Measures
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab
Timeframe: Day 1 to Day 64
AUC from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab
Timeframe: Day 1 to Day 64
Maximum Observed Concentration (Cmax) of Evolocumab
Timeframe: Day 1 to Day 64
Secondary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 to Day 64
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to Day 64
Number of Participants with Anti-evolocumab Antibody Formation
Timeframe: Day 1 and Day 64
Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C)
Timeframe: Day 1 to Day 64
Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Timeframe: Day 1 to Day 64
Locations
Location
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247
Status
Recruiting
Location
QPS Bio-Kinetic
Springfield, MO, United States, 65802
Status
Recruiting
Location
Anaheim Clinical Trials
Anaheim, California, United States, 92801-2658
Status
Recruiting
Location
Quest Pharmaceutical Services - Miami Research Associates - Early Phase
South Miami, FL, United States, 33143
Status
Recruiting