Eligibility Details:
Inclusion Criteria:
1. Subject signs an institutional review board (IRB)-approved written informed consent
and privacy language as per national regulations (e.g., Health Insurance Portability
and Accountability Act authorization) before any study related procedures are
performed.
2. Subject is a healthy man or woman, 18 to 55 years of age, inclusive, who has a body
mass index of 18.5 to 32 kg/m2, inclusive, at Screening.
3. Subject has a LDL-C level >=100 and <=190 mg/dL inclusive, at Screening.
4. Subject has normal medical history findings, clinical laboratory results, vital sign
measurements, 12 lead electrocardiogram (ECG) results, and physical examination
findings at Screening or, if abnormal, the abnormality is not considered clinically
significant (as determined and documented by the investigator or designee).
5. Subject must have a negative test result for alcohol and drugs of abuse at screening
and Check-in (Day -1).
6. Female subjects must be of non-childbearing potential or, if they are of childbearing
potential, they must: 1) have been strictly abstinent for 1 month before Check in (Day
-1) and agree to remain strictly abstinent for the duration of the study and for at
least 1 month after the last application of study drug; OR 2) be practicing 2 highly
effective methods of birth control (as determined by the investigator or designee; one
of the methods must be a barrier technique) from at least 1 month before Check in (Day
-1) until at least 1 month after the last application of study drug.
7. Male subjects must agree to practice 1 highly effective method of birth control (as
determined by the investigator or designee) from at least 1 month before Check in
(Day-1) until at least 1 month after the last application of study drug.
8. Subject is highly likely (as determined by the investigator) to comply with the
protocol defined procedures as to complete the study.
Exclusion Criteria:
1. Subject is taking cholesterol medication (e.g. statins).
2. Subject is anemic (i.e., with hematocrit or hemoglobin less than the lower limit of
normal) or has any chronic condition(s) that may impact blood sample collection.
3. Subject has had previous exposure to the biologic evolocumab or alirocumab.
4. Subject has a history of asthma.
5. Subject has a history of anaphylaxis from environmental exposures such as peanuts or
bee stings.
6. Subject has an allergic history that includes urticaria, angioedema or respiratory
coughing or bronchospasm.
7. Subject has a history of severe local reactions or generalized erythema from skin
allergen testing.
8. Subject has used any prescription or nonprescription drugs (including aspirin or
NSAIDs and excluding oral contraceptives and acetaminophen) within 14 days or 5
half-lives (whichever is longer) or complementary and alternative medicines within 28
days before the first dose of study drug.
9. Subjects are currently participating in another clinical study of an investigational
drug or are have been treated with any investigational drug within 30 days or 5
half-lives (whichever is longer) of the compound.
10. Subject has used nicotine-containing products (e.g., cigarettes, cigars, chewing
tobacco, snuff) within 6 weeks of Screening.
11. Subject has consumed alcohol, xanthine containing products (e.g., tea, coffee,
chocolate, cola), caffeine, grapefruit, or grapefruit juice within 48 hours of dosing.
Subjects must refrain from ingesting these throughout the study.
12. Subject has any underlying disease or surgical or medical condition (e.g., cancer,
human immunodeficiency virus [HIV], severe hepatic or renal impairment) that could put
the subject at risk or would normally prevent participation in a clinical study.
13. Subject has known or suspected allergies or sensitivities to any study drug.
14. Subject has clinical laboratory test results (hematology, serum chemistry lipid panel
and comprehensive metabolic panel) at Screening that are outside the reference ranges
provided by the clinical laboratory and considered clinically significant by the
investigator.
15. Subject has a positive test result at Screening for human immunodeficiency virus (HIV)
1 or 2 antibody, hepatitis C virus load, hepatitis C virus antibodies, or hepatitis B
surface antigen.
16. Subject is unable or unwilling to undergo multiple venipunctures for blood sample
collection because of poor tolerability or poor venous access.
17. Female subjects are pregnant or lactating before enrollment in the study
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
