Overview
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
Eligibility
Inclusion Criteria
- Male or female, of any race, between 18 and 60 years of age, inclusive.
- 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- Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.