Actively Recruiting
An Open-label, Phase 1, Single Dose, Randomized Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab Drug Products
Led by Amgen · Updated on 2026-04-16
400
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is designed to study how two different evolocumab drug products are processed in the body of healthy adult participants. The primary goal is to compare the pharmacokinetics, which means measuring how the drug is absorbed, distributed, metabolized, and eliminated over time. The study is a Phase 1, randomized, open-label trial focused on healthy volunteers aged 18 to 60 years. Participants will be randomly assigned to receive a single subcutaneous dose of either evolocumab drug substance A or evolocumab drug substance B. The study is parallel-group, meaning each participant receives only one of the two treatments for comparison. Both drug products are given as a one-time injection under the skin. Throughout the study, participants will be monitored from Day 1 to Day 64 to measure drug levels in the blood, including the area under the concentration-time curve and the maximum concentration achieved. Safety is also assessed by tracking any adverse events and antibody formation against evolocumab. Additional blood tests will measure effects on cholesterol and PCSK9 protein levels. This comprehensive monitoring ensures detailed evaluation of the drug behavior and participant safety over the study period.
CONDITIONS
Brief 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, aged between 18 and 60 years inclusive
- Females must not be pregnant or lactating
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m² inclusive
- LDL cholesterol level between 70 and 190 mg/dL at screening
You will not qualify if you...
- History or evidence of any clinically significant disorder or disease that poses risk or interferes with the study
- History or current signs or symptoms of cardiovascular disease
- History or evidence of clinically significant arrhythmia
- History of allergy or intolerance to evolocumab or similar biological drugs
- Uncontrolled hyperthyroidism or hypothyroidism
- Use of any medications, herbal medicines, vitamins or supplements within 30 days before check-in
- Participation in another investigational drug or device trial within 30 days before check-in
- Previous participation or withdrawal from this or other evolocumab or PCSK9 inhibitor trials or prior receipt of such treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single subcutaneous dose of one of two evolocumab drug substances.
1 dosing visit (in-person)
Duration - Up to 64 days
Participants are monitored for safety and drug effects after the single dose.
Multiple visits for assessments up to Day 64
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
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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