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

NCT07422285 — Phase 1, Completed, 405 participants, Amgen

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An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products

RegistryNCT07422285
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: none, basic science
Enrollment405 (Actual)
SponsorAmgen (Industry)
ConditionsHealthy Participants, Pharmacokinetics
InterventionsEvolocumab Drug Substance A, Evolocumab Drug Substance B (Drug)
Datesstart 2026-01-16, primary completion 2026-07-24, completion 2026-07-24, first posted 2026-02-20, last updated 2026-08-17
Locations4 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Participants All trials for Pharmacokinetics All trials of Evolocumab Drug Substance A All trials of Evolocumab Drug Substance B

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Evolocumab Drug Substance AExperimentalDrug: Evolocumab Drug Substance AParticipants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.
Evolocumab Drug Substance BExperimentalDrug: Evolocumab Drug Substance BParticipants will receive a single SC dose of evolocumab drug substance B.
  • Evolocumab Drug Substance A (Drug), also known as AMG 145: Evolocumab drug substance A will be administered SC.
  • Evolocumab Drug Substance B (Drug), also known as AMG 145: Evolocumab drug substance B will be administered SC.

+Outcome measures

Primary outcomes

  • Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab [Day 1 to Day 64]
  • Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab [Day 1 to Day 64]
  • Maximum Observed Concentration (Cmax) of Evolocumab [Day 1 to Day 64]

Secondary outcomes

  • Number of Participants with Treatment-emergent Adverse Events [Day 1 to Day 64]
  • Number of Participants with Serious Adverse Events [Up to Day 64]
  • Number of Participants with Anti-evolocumab Antibody Formation [Day 1 and Day 64]
  • Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C) [Day 1 to Day 64]
  • Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) [Day 1 to Day 64]

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria

1. Male or female, of any race, between 18 and 60 years of age, inclusive.

   a. Females must not be pregnant or lactating.
2. Body Mass Index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive.
3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

Exclusion Criteria

1. History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
2. History or current signs or symptoms of cardiovascular disease.
3. History or evidence of clinically significant arrhythmia.
4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs.
5. Uncontrolled hyperthyroidism or hypothyroidism.
6. Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in.
7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.
8. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor.

+Locations (4)

FacilityCityCountryStatus
QPS Bio-KineticSpringfield, MissouriUnited States
Ohio Clinical Trials, Inc.Columbus, OhioUnited States
Fortrea Clinical Research Unit - DallasDallas, TexasUnited States
Fortrea Clinical Research Unit Inc. - MadisonMadison, WisconsinUnited States

+Investigators

  • MD, Study director, Amgen