A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).

The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.

Inclusion Criteria:

• Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
• Planned for primary PCI (percutaneous coronary intervention)
• Men and women without child-bearing potential aged 30-80 years of age
• Capable and willing to provide informed consent.
• Capable of completing study visits

Exclusion Criteria:

• Fibrinolytic administration for index event
• Known prior MI or prior coronary artery bypass graft (CABG) surgery
• Known pre-existing cardiomyopathy
• History of anaphylaxis
• Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)