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

Part of paid clinical trials in Anaheim, California.

Sponsor
Amgen
Study ID
NCT07545226
Phase
PHASE1
Status
Active Not Recruiting

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

First listed
Apr 22, 2026
Start date
Apr 21, 2026
Status verified
Jul 2026
Primary completion
Sep 3, 2026
Completion
Sep 3, 2026

Study Design

Enrollment
405 participants (actual)
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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801-2658-
Quest Pharmaceutical Services - Miami Research Associates - Early PhaseSouth MiamiFlorida33143-
QPS Bio-KineticSpringfieldMissouri65802-
Fortrea Clinical Research Unit - DallasDallasTexas75247-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials· Anaheim, CAQuest Pharmaceutical Services - Miami Research Associates - Early Phase· South Miami, FLQPS Bio-Kinetic· Springfield, MOFortrea Clinical Research Unit - Dallas· Dallas, TX

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