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.

Sponsor ID
20250012
Clinicaltrials.gov ID
NCT07545226
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.

Additional Study Details

Phase
Phase 1
Product
AMG 145
Type
Interventional
Masking
None (Open Label)
Enrollment
405
Additional Study Details

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
Status
Contact Us
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