Condition: Healthy Participants · Sponsor: Amgen
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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 Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Anaheim Clinical Trials | Anaheim, California, United States | — |
| Quest Pharmaceutical Services - Miami Research Associates - Early Phase | South Miami, Florida, United States | — |
| QPS Bio-Kinetic | Springfield, Missouri, United States | — |
| Fortrea Clinical Research Unit - Dallas | Dallas, Texas, United States | — |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.