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

NCT07545226 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 20250012
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.

Conditions

Healthy Participants

Keywords

Evolocumab; AMG 145; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

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

  Day 1 to Day 64

• AUC 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 (5)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Day 1 to Day 64

• Number of Participants with Serious Adverse Events (SAEs)

  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

Study Arms (2)

Evolocumab Drug Substance A (Test)

EXPERIMENTAL

Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.

Drug: Evolocumab Drug Substance A (Test)

Evolocumab Drug Substance B (Reference)

EXPERIMENTAL

Participants will receive a single SC dose of evolocumab drug substance B.

Drug: Evolocumab Drug Substance B (Reference)

Interventions

Evolocumab Drug Substance A (Test) DRUG

Evolocumab drug substance A will be administered SC.

Also known as: AMG 145

Evolocumab Drug Substance A (Test)

Evolocumab Drug Substance B (Reference) DRUG

Evolocumab drug substance B will be administered SC.

Also known as: AMG 145

Evolocumab Drug Substance B (Reference)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

evolocumab

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.