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

Last updated: April 15, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Evolocumab Drug Substance A

Evolocumab Drug Substance B

Clinical Study ID

NCT07422285
20240180
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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.

  1. Body Mass Index (BMI) between 18.0 and 32.0 kg/m^2 inclusive.

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 Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Evolocumab Drug Substance A
Phase: 1
Study Start date:
January 16, 2026
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach, Florida 32117-5116
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach 4152872, Florida 4155751 32117-5116
    United States

    Site Not Available

  • Fortrea Clinical Research Unit- Daytona Beach

    Daytona Beach 4152872, Florida 4155751 32117
    United States

    Active - Recruiting

  • QPS Bio-Kinetic

    Springfield, Missouri 65802-4842
    United States

    Active - Recruiting

  • QPS Bio-Kinetic

    Springfield 4409896, Missouri 4398678 65802-4842
    United States

    Site Not Available

  • QPS Bio-Kinetic (MO)

    Springfield 4409896, Missouri 4398678 65807
    United States

    Active - Recruiting

  • Ohio Clinical Trials, Inc.

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit - Dallas

    Dallas, Texas 75247
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit - Dallas

    Dallas 4684888, Texas 4736286 75247
    United States

    Site Not Available

  • Fortrea Clinical Research Unit- Dallas

    Dallas 4684888, Texas 4736286 75247
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit Inc. - Madison

    Madison, Wisconsin 53704-2526
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit - Madison

    Madison 5261457, Wisconsin 5279468 53704
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit Inc. - Madison

    Madison 5261457, Wisconsin 5279468 53704-2526
    United States

    Site Not Available

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