To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, CAD
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
MEDI6012 24 mg IV
MEDI6012 80 mg IV
MEDI6012 240 mg IV
MEDI6012 800 mg IV
MEDI6012 80 mg SC
Placebo Intravenous (IV)
MEDI6012 600 mg SC
Placebo Subcutaneous (SC)
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.