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RECRUITING
NCT07422285
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 main objective of this trial is to evaluate the pharmacokinetics 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

2026-01-16

Completion Date

2026-07-07

Last Updated

2026-03-17

Healthy Volunteers

Yes

Interventions

DRUG

Evolocumab Drug Substance A

Evolocumab drug substance A will be administered SC.

DRUG

Evolocumab Drug Substance B

Evolocumab drug substance B will be administered SC.

Locations (4)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

QPS Bio-Kinetic

Springfield, Missouri, United States

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States