Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease

A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety,
Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects
with Stable Atherosclerotic Cardiovascular Disease

Inclusion Criteria:

- Non-childbearing potential

- Diagnosis of stable atherosclerotic CVD

- Currently receiving a stable dose of Statin

Exclusion Criteria:

- Unstable cardiovascular condition within 3 months of screening

- Elective arterial revascularization with in the past month

- Any planned arterial revascularization

- Body mass index <18 or >45

- Clinically significant ECG that may interfere with the interpretation of serial ECG
and QT interval changes at screening

- Chronic kidney disease defined by estimated glomerular filtration rate of less than 30
mL/mim/1.73m2

- Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater
than 60 for males, or 65 for females

- Clinically significant vital sign abnormalities

- Genetic disorder of cholesterol metabolism

- History of overt liver disease

- Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)

- Current or recent use of systemic corticosteroids

- Recent or ongoing infection or febrile illness

- History of active malignancy within 5 years

- History of alcohol or recreational substance abuse in the past 6 months

- Concurrent enrollment in another clinical study of any investigational drug therapy or
use of any biologicals within 6 months prior to screening or within 5 half-lives of an
investigational agent or biologic, whichever is longer.