Phase
Condition
N/ATreatment
Evolocumab Drug Substance A
Evolocumab Drug Substance B
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
- 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.
Exclusion Criteria
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Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.
Study Design
Connect with a study center
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida 32117-5116
United StatesActive - Recruiting
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach 4152872, Florida 4155751 32117-5116
United StatesSite Not Available
Fortrea Clinical Research Unit- Daytona Beach
Daytona Beach 4152872, Florida 4155751 32117
United StatesActive - Recruiting
QPS Bio-Kinetic
Springfield, Missouri 65802-4842
United StatesActive - Recruiting
QPS Bio-Kinetic
Springfield 4409896, Missouri 4398678 65802-4842
United StatesSite Not Available
QPS Bio-Kinetic (MO)
Springfield 4409896, Missouri 4398678 65807
United StatesActive - Recruiting
Ohio Clinical Trials, Inc.
Columbus, Ohio 43212
United StatesActive - Recruiting
Fortrea Clinical Research Unit - Dallas
Dallas, Texas 75247
United StatesActive - Recruiting
Fortrea Clinical Research Unit - Dallas
Dallas 4684888, Texas 4736286 75247
United StatesSite Not Available
Fortrea Clinical Research Unit- Dallas
Dallas 4684888, Texas 4736286 75247
United StatesActive - Recruiting
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin 53704-2526
United StatesActive - Recruiting
Fortrea Clinical Research Unit - Madison
Madison 5261457, Wisconsin 5279468 53704
United StatesActive - Recruiting
Fortrea Clinical Research Unit Inc. - Madison
Madison 5261457, Wisconsin 5279468 53704-2526
United StatesSite Not Available

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