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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 75
Updated:4/17/2018
Start Date:December 3, 2015
End Date:November 3, 2016

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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
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