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OpenTrials
Active, Not Recruiting

NCT Number: NCT07422285

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit - Daytona Beach, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

a. Females must not be pregnant or lactating.

  • Body Mass Index (BMI) between 18.0 and 32.0 kg/m^2 inclusive.
  • LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

Exclusion criteria

  • 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.
  • History or current signs or symptoms of cardiovascular disease.
  • History or evidence of clinically significant arrhythmia.
  • History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs.
  • Uncontrolled hyperthyroidism or hypothyroidism.
  • 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.
  • Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.
  • Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.

Treatment and study plan

Evolocumab Drug Substance A

Drug

Evolocumab drug substance A will be administered SC.

Other names: AMG 145

Evolocumab Drug Substance B

Drug

Evolocumab drug substance B will be administered SC.

Other names: AMG 145

Primary outcomes

  1. Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab

    Time frame: Day 1 to Day 64

  2. Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab

    Time frame: Day 1 to Day 64

  3. Maximum Observed Concentration (Cmax) of Evolocumab

    Time frame: Day 1 to Day 64

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events

    Time frame: Day 1 to Day 64

  2. Number of Participants with Serious Adverse Events

    Time frame: Up to Day 64

  3. Number of Participants with Anti-evolocumab Antibody Formation

    Time frame: Day 1 and Day 64

  4. Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: Day 1 to Day 64

  5. Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Time frame: Day 1 to Day 64

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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