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 Daytona Beach, Florida.

Sponsor
Amgen
Study ID
NCT07422285
Phase
PHASE1
Status
Recruiting
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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

Start date
Jan 16, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
400 participants (estimated)
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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit - Daytona BeachDaytona BeachFlorida32117-5116-
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 Daytona Beach, FL

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Fortrea Clinical Research Unit - Daytona Beach· Daytona Beach, FLQPS 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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