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

To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.

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.