Visual Abstract - A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure: 10.1016/j.jacbts.2016.09.005

• Cimaglermin is a recombinant neuregulin that appears to be important for essential cardiac repair processes.

• Forty patients with significant left ventricular dysfunction and heart failure were randomized in a phase 1 double blind, placebo controlled, single ascending dose study to examine safety and tolerability.

• An infusion of cimaglermin was generally tolerated except for transient nausea and headache.

• A dose-limiting toxicity of transient elevated liver transaminases and bilirubin was observed at the highest planned dose.

• There was a sustained improvement in left ventricular ejection fraction over 3 months at higher doses tested compared to lower doses or placebo.