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

Running, not enrolling · Phase 1

Conditions studied: Healthy Participants, Pharmacokinetics

In brief

The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.

Key facts

Study ID

NCT07422285

Run by

Amgen

People needed

405

Starts

2026-01-16

Expected to finish

2026-07-24

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, of any race, between 18 and 60 years of age, inclusive.
• a. Females must not be pregnant or lactating.
• Body Mass Index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive.
• LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

You may not qualify if…

• History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
• History or current signs or symptoms of cardiovascular disease.
• History or evidence of clinically significant arrhythmia.
• History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs.
• Uncontrolled hyperthyroidism or hypothyroidism.
• Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in.
• Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.
• Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor.

Where it is running

• Fortrea Clinical Research Unit - Daytona Beach — Daytona Beach, Florida, United States
• QPS Bio-Kinetic — Springfield, Missouri, United States
• Ohio Clinical Trials, Inc. — Columbus, Ohio, United States
• Fortrea Clinical Research Unit - Dallas — Dallas, Texas, United States
• Fortrea Clinical Research Unit Inc. - Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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