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Purpose

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts 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 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 Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Evolocumab Drug Substance A (Test) 		Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.
  • Drug: Evolocumab Drug Substance A (Test)
    Evolocumab drug substance A will be administered SC.
    Other names:
    • AMG 145
Experimental
Evolocumab Drug Substance B (Reference) 		Participants will receive a single SC dose of evolocumab drug substance B.
  • Drug: Evolocumab Drug Substance B (Reference)
    Evolocumab drug substance B will be administered SC.
    Other names:
    • AMG 145

Recruiting Locations

Anaheim Clinical Trials
Anaheim, California 92801-2658

Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida 32117-5116

Quest Pharmaceutical Services - Miami Research Associates - Early Phase
South Miami, Florida 33143

QPS Bio-Kinetic
Springfield, Missouri 65802

Fortrea Clinical Research Unit - Dallas
Dallas, Texas 75247

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.