An Open-Label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
Amgen
Summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
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 symptom…
Interventions
- DrugEvolocumab Drug Substance A (Test)
Evolocumab drug substance A will be administered SC.
- DrugEvolocumab Drug Substance B (Reference)
Evolocumab drug substance B will be administered SC.
Locations (5)
- Anaheim Clinical TrialsAnaheim, California
- Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, Florida
- Quest Pharmaceutical Services - Miami Research Associates - Early PhaseSouth Miami, Florida
- QPS Bio-KineticSpringfield, Missouri
- Fortrea Clinical Research Unit - DallasDallas, Texas