Faraday Pharmaceuticals, a biopharmaceutical company, announced the start of a phase 1 clinical trial evaluating its lead compound FDY-5301.
The randomized, double blind, placebo-controlled trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single, escalating, intravenous doses of FDY-5301 versus placebo in healthy volunteers. FDY-5301 contains elemental iodine in its reduced form – iodide – formulated for intravenous administration.
Preclinical data have demonstrated the ability of FDY-5301 to diminish reperfusion injury in both cardiac and skeletal muscle in a range of different animal models and in multiple species. The phase 1 trial is being conducted in Australia and is targeted to enroll approximately 40 subjects.
"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. Our elemental reducing agents have demonstrated compelling activity in a number of animal studies, including models of cardiac reperfusion, radiation injury and organ transplantation," said Stephen A. Hill, M.D., chief executive officer of Faraday. "We are working hard on our phase 2 preparations in hope of providing new options to patients as expeditiously as possible."
Faraday Pharmaceuticals is a biopharmaceutical company focused on the research and development of elemental reducing agents (ERAs).