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.
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 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