Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
- Summary
- The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
- Short title
- Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
- Official title
- An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-07-24
- First posted
- 2026-02-20
- Registry last updated
- 2026-08-17
- Primary completion date
- 2026-07-24
- Start date
- 2026-01-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07422285
- ClinicalTrials.gov ID
- NCT07422285
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab
Timeframe: Day 1 to Day 64
Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab
Timeframe: Day 1 to Day 64
Maximum Observed Concentration (Cmax) of Evolocumab
Timeframe: Day 1 to Day 64
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Day 1 to Day 64
Number of Participants with Serious Adverse Events
Timeframe: Up to Day 64
Number of Participants with Anti-evolocumab Antibody Formation
Timeframe: Day 1 and Day 64
Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C)
Timeframe: Day 1 to Day 64
Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Timeframe: Day 1 to Day 64
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
-
Male or female, of any race, between 18 and 60 years of age, inclusive.
a. 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.
- 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.
- QPS Bio-KineticSpringfield, United States
- Ohio Clinical Trials, Inc.Columbus, United States
- Fortrea Clinical Research Unit - DallasDallas, United States
- Fortrea Clinical Research Unit Inc. - MadisonMadison, United States
- Related resource (www.amgentrials.com)