Compare how two evolocumab products enter the body after one under-the-skin dose

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

We will test whether two different evolocumab formulations reach the bloodstream similarly after a single under-the-skin dose in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Amgen (Industry-sponsored)
• Drugs / interventions: evolocumab
• Locations: 5 sites (Daytona Beach, Florida and 4 other locations)
• Trial ID: NCT07422285 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial compares the pharmacokinetics of two evolocumab drug products after a single subcutaneous dose in healthy adults. Participants aged 18 to 60 with BMI 18.0–32.0 kg/m2 and LDL-C between 70 and 190 mg/dL will receive one dose of either formulation and have blood samples taken over time to measure drug concentrations. Screening and safety assessments exclude people with cardiovascular disease, significant arrhythmias, uncontrolled thyroid disease, recent medication use, or a known hypersensitivity to evolocumab. The trial is sponsored by Amgen and is conducted at three U.S. clinical research sites.

Who should consider this trial

Good fit: Healthy adults 18 to 60 years old with BMI 18.0–32.0 kg/m2 and LDL-C 70–190 mg/dL who are not pregnant or lactating and have no history of cardiovascular disease or hypersensitivity to evolocumab.

Not a fit: People with active cardiovascular disease, significant arrhythmias, uncontrolled thyroid disease, recent use of medications or supplements within 30 days, pregnancy, or known allergy to evolocumab would not be expected to benefit and are excluded.

Why it matters

Potential benefit: If the two formulations show similar blood levels, manufacturers may be able to use either product interchangeably, which could improve supply flexibility and patient access.

How similar studies have performed: Previous pharmacokinetic and bioequivalence studies of evolocumab formulations have been conducted and generally shown consistent PK profiles, so this approach builds on existing evidence.

Eligibility criteria

Inclusion Criteria

1. Male or female, of any race, between 18 and 60 years of age, inclusive.

   a. Females must not be pregnant or lactating.
2. Body Mass Index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive.
3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

Exclusion Criteria

1. 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.
2. History or current signs or symptoms of cardiovascular disease.
3. History or evidence of clinically significant arrhythmia.
4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs.
5. Uncontrolled hyperthyroidism or hypothyroidism.
6. 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.
7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.
8. 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 this trial is running

Daytona Beach, Florida and 4 other locations

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

Study contacts

• Study coordinator: Amgen Call Center

Conditions Healthy Participants; Pharmacokinetics; Evolocumab; AMG 145