Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT07422285

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

Led by Amgen · Updated on 2026-04-16

400

Participants Needed

5

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, of any race, between 18 and 60 years of age, inclusive
  • Females must not be pregnant or lactating
  • Body Mass Index (BMI) between 18.0 and 32.0 kg/m² inclusive
  • LDL-C level 53 70 mg/dL (1.8 mmol/L) and 54 190 mg/dL (4.9 mmol/L) at screening
Not Eligible

You will not qualify if you...

  • History or evidence of any clinically significant disorder, condition, or disease that poses a risk or interferes with the trial
  • 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 or prior use of medications, herbal medicines, vitamins, or supplements within 30 days or 5 half-lives prior to check-in
  • Participation in another investigational drug or device trial within the past 30 days or 5 half-lives prior to check-in
  • Previous participation in this trial or any trial investigating evolocumab, PCSK9 inhibitors, or similar products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States, 32117-5116

Actively Recruiting

2

QPS Bio-Kinetic

Springfield, Missouri, United States, 65802-4842

Actively Recruiting

3

Ohio Clinical Trials, Inc.

Columbus, Ohio, United States, 43212

Actively Recruiting

4

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States, 75247

Actively Recruiting

5

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States, 53704-2526

Actively Recruiting

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Research Team

A

Amgen Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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