Evolocumab Drug Substance A (Test)Evolocumab Drug Substance B (Reference)
Evolocumab Drug Substance A (Test): Evolocumab drug substance A will be administered SC.
Evolocumab Drug Substance B (Reference): Evolocumab drug substance B will be administered SC.
Study summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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 Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.
Primary outcome measure(s)
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
Trial sites (4)
Facility
City
Region
Status
Anaheim Clinical Trials
Anaheim
California
Quest Pharmaceutical Services - Miami Research Associates - Early Phase
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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