The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Male or female, of any race, between 18 and 60 years of age, inclusive.
Body mass index (BMI) between 18.0 and 32.0 kg/m² inclusive.
LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.
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.
Parallel
Evolocumab Drug Substance A (Test)
DrugEvolocumab drug substance A will be administered SC.
Evolocumab Drug Substance B (Reference)
DrugEvolocumab drug substance B will be administered SC.
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab
AUC from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab
Maximum Observed Concentration (Cmax) of Evolocumab
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Anti-evolocumab Antibody Formation
Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C)
