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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02601560

Run by

MedImmune LLC

People needed

48

Starts

2015-12-03

Expected to finish

2016-11-03

Last updated by the study team

2018-03-19

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Research Site — Anniston, Alabama, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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