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 |
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.
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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