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

Sponsor
Amgen
Study ID
NCT07545226
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Sep 8, 2026
Completion
Sep 8, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Evolocumab Drug Substance A (Test)
    Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.
  • Experimental: Evolocumab Drug Substance B (Reference)
    Participants will receive a single SC dose of evolocumab drug substance B.

Primary Outcome Measure

Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab [ Time Frame: Day 1 to Day 64 ]

Central Contacts

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