Phase 1 Evolocumab PK Study, Single Dose, Healthy
Summary
NIH registered Phase 1 clinical trial NCT07545226 on April 22, 2026, a pharmacokinetics study comparing two evolocumab drug products in healthy participants. The trial will evaluate Drug Substance A (Test) against Drug Substance B (Reference) following a single subcutaneous dose. This study is classified as Phase 1 and targets healthy participants without specified medical conditions.
“The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.”
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What changed
NIH registered a new Phase 1 clinical trial on ClinicalTrials.gov under identifier NCT07545226. The study's primary objective is to evaluate and compare the pharmacokinetics of two evolocumab drug products following a single subcutaneous dose in healthy participants. Drug Substance A is designated as the test product while Drug Substance B serves as the reference.
For pharmaceutical companies and clinical researchers monitoring evolocumab or biosimilar development, this registration indicates ongoing bioequivalence or comparative bioavailability evaluation activity. Sponsors developing evolocumab biosimilars or reference-product comparators may need to track this study as it may inform regulatory expectations for PK similarity assessments.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.
Phase 1 NCT07545226 Kind: PHASE1 Apr 22, 2026
Abstract
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Conditions: Healthy Participants
Interventions: Evolocumab Drug Substance A (Test), Evolocumab Drug Substance B (Reference)
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