RecruitingPhase 1NCT07422285

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

An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products

Sponsor

Amgen

Enrollment

400 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants Pharmacokinetics

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

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.

Exclusion Criteria8

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Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.