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

{ "Comparing Evolocumab Drug Products in Healthy Participants", "This study is comparing two different versions of a drug called evolocumab (Evolocumab Drug Substance A and Evolocumab Drug Substance B). Researchers want to see how much of each drug gets into your body and how long it stays there after a single shot under the skin. This helps them understand if the two versions are absorbed similarly. You might be able to join if you are a healthy adult between 18 and 60 years old, with a specific Body Mass Index (BMI) and certain cholesterol levels (LDL-C). The study aims to measure the drug levels in your body over about two months to see if the two evolocumab products are alike. The current recruitment status is unclear, and the study plans to enroll 405 participants.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 405 healthy participants.", "commitments": "Not specified in the trial record.", "compensation": "Not stated in the trial record.", "follow_up": "Drug levels will be measured from Day 1 to Day 64 after receiving the evolocumab.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07422285

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

Completed
PHASE1Ages 18–60InterventionalBasic science
Amgen
~405 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Evolocumab Drug Substance AEvolocumab Drug Substance B

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab
Measured over Day 1 to Day 64
+2 more outcomes measured
Healthy Participants
Pharmacokinetics
4 sites across 4 states
Missouri1
Ohio1
Texas1
Wisconsin1
  • MD · STUDY_DIRECTOR · Amgen

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of EvolocumabDay 1 to Day 64
  • Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of EvolocumabDay 1 to Day 64
  • Maximum Observed Concentration (Cmax) of EvolocumabDay 1 to Day 64