An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
| Registry | NCT07422285 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 405 (Actual) |
| Sponsor | Amgen (Industry) |
| Conditions | Healthy Participants, Pharmacokinetics |
| Interventions | Evolocumab Drug Substance A, Evolocumab Drug Substance B (Drug) |
| Dates | start 2026-01-16, primary completion 2026-07-24, completion 2026-07-24, first posted 2026-02-20, last updated 2026-08-17 |
| Locations | 4 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
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Evolocumab Drug Substance A | Experimental | Drug: Evolocumab Drug Substance A | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
| Evolocumab Drug Substance B | Experimental | Drug: Evolocumab Drug Substance B | Participants will receive a single SC dose of evolocumab drug substance B. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| QPS Bio-Kinetic | Springfield, Missouri | United States | |
| Ohio Clinical Trials, Inc. | Columbus, Ohio | United States | |
| Fortrea Clinical Research Unit - Dallas | Dallas, Texas | United States | |
| Fortrea Clinical Research Unit Inc. - Madison | Madison, Wisconsin | United States |