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 Springfield, Missouri.

Sponsor
Amgen
Study ID
NCT07422285
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.

Key Dates

First listed
Feb 20, 2026
Start date
Jan 16, 2026
Status verified
Aug 2026
Primary completion
Jul 24, 2026
Completion
Jul 24, 2026

Study Design

Enrollment
405 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Evolocumab Drug Substance A
    Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.
  • Experimental: Evolocumab Drug Substance B
    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
QPS Bio-KineticSpringfieldMissouri65802-4842-
Ohio Clinical Trials, Inc.ColumbusOhio43212-
Fortrea Clinical Research Unit - DallasDallasTexas75247-
Fortrea Clinical Research Unit Inc. - MadisonMadisonWisconsin53704-2526-

Find similar trials in Springfield, MO

By research site
QPS Bio-Kinetic· Springfield, MOOhio Clinical Trials, Inc.· Columbus, OHFortrea Clinical Research Unit - Dallas· Dallas, TXFortrea Clinical Research Unit Inc. - Madison· Madison, WI

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