Aegis

A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

Aegis [NCT02108262]

Description: This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

Biological: CSL112; Biological: Placebo

Primary Investigator: Sarembock

Drug/Device Information
Investigate the hepatic and renal safety and tolerability of multiple dose administration of CSL112 in subjects with Acute MI
CSL112 is a novel formulation of apoA-I purified from human plasma and reconstituted to form HDL particles
Lead in 8 pts randomized 3:1(single 2g CSL112:placebo)
Main study randomized 1:1:1 (2g CSL112 : 6g CSL112 : placebo) X four infusions
CSL Behring LLC
Major Inclusion and Exclusion
Age ≥ 18 with acute MI and stable renal function defined as an increase in serum creatinine <0.3 mg/dL from the pre-contrast value
No ongoing hemodynamic instability
No LVEF <30%
No eGFR < 60 or history of AKI after previous exposure to an IV contrast agent
No weight < 50 kg
No allergy to soybean or peanuts