The trial, which will be randomized, double-blind and placebo-controlled, will see to the administering of a single, escalating, intravenous dose of FDY-5301 to enrolled patients. The drug will be compared to placebo.
"It's gratifying to begin this first-in-human study following the promising preclinical findings to date, and less than six months after our initial 'GLP' toxicity studies were initiated," Faraday CEO Dr. Stephen A. Hill said. "Our elemental reducing agents have demonstrated compelling activity in a number of animal studies, including models of cardiac reperfusion, radiation injury and organ transplantation. We are working hard on our Phase 2 preparations in hope of providing new options to patients as expeditiously as possible."
Preclinical data suggests that FDY-5301 has the potential to reduce reperfusion injury in cardiac and skeletal muscles in a number of various animal models as well as in different species. The clinical study, which will see the enrollment of 40 patients, is being conducted in Australia.
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