To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease

A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- Ascending Doses of MEDI6012 in Subjects With Stable Coronary Artery Disease

This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.

Inclusion Criteria:

• Men and women 40 - 75 years old
• History of Stable CAD
• Currently receiving statin as standard of care

Exclusion Criteria:

• Severe angina pectoris symptoms
• High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period
• Hospitalization for heart failure within 12 months prior to screening
• Uncontrolled Hypertension
• Within 6 months prior to screening, a history of ACS or hospitalization for heart failure
• Clinically significant abnormalities in rhythm, conduction or morphology of ECG
• Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
• Untreated life-threatening ventricular arrhythmias
• History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease
• Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period