Actively Recruiting
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
Eligibility Criteria
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
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
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
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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