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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics; Healthy Participants
• Intervention / Treatment: Drug: Evolocumab Drug Substance A; Drug: Evolocumab Drug Substance B

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117-5116
      • Recruiting
      • Fortrea Clinical Research Unit - Daytona Beach
  • Missouri
    • Springfield, Missouri, United States, 65802-4842
      • Recruiting
      • QPS Bio-Kinetic
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Ohio Clinical Trials, Inc.
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • Fortrea Clinical Research Unit - Dallas
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Recruiting
      • Fortrea Clinical Research Unit Inc. - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evolocumab Drug Substance A; Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.	Drug: Evolocumab Drug Substance A; Evolocumab drug substance A will be administered SC.; Other Names: AMG 145
Experimental: Evolocumab Drug Substance B; Participants will receive a single SC dose of evolocumab drug substance B.	Drug: Evolocumab Drug Substance B; Evolocumab drug substance B will be administered SC.; Other Names: AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Evolocumab; AMG 145
• Additional Relevant MeSH Terms: evolocumab
• Other Study ID Numbers: 20240180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No