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RECRUITING
NCT07545226
PHASE1

Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.

Sponsor: Amgen

View on ClinicalTrials.gov

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

Interventions

DRUG

Evolocumab Drug Substance A (Test)

Evolocumab drug substance A will be administered SC.

DRUG

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