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Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.
Sponsor: Amgen
Summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Official title: An Open-Label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-04-21
Completion Date
2026-09-08
Last Updated
2026-07-01
Healthy Volunteers
Yes
Conditions
Interventions
Evolocumab Drug Substance A (Test)
Evolocumab drug substance A will be administered SC.
Evolocumab Drug Substance B (Reference)
Evolocumab drug substance B will be administered SC.
Locations (5)
Anaheim Clinical Trials
Anaheim, California, United States
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
Quest Pharmaceutical Services - Miami Research Associates - Early Phase
South Miami, Florida, United States
QPS Bio-Kinetic
Springfield, Missouri, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States