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

StatusCompleted
PhasePhase 1
SponsorAmgen
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 3, 2026 to Sep 2, 2026
    • Study completion date changed from estimate of Sep 3, 2026 to Sep 8, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 405
    • Study sites: 5 to 4
    • Primary and study completion dates: Sep 8, 2026 to Sep 3, 2026
    v3
  3. Recruitment opened
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of Apr 20, 2026 to Apr 21, 2026
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Amgen
169 trials monitored
See 11 trials at risk
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Trial Details
NCT Number NCT07545226
Lead Sponsor Amgen
Conditions
(from sponsor)		 Healthy Participants
Enrollment 405 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov