US-based biopharmaceutical company Faraday has initiated its first in-human Phase I clinical trial of FDY-5301 as an elemental reducing agent (ERA).
FDY-5301 is Faraday’s lead compound consisting of elemental iodine in its reduced form, iodide, and has been developed to be administered intravenously.
The randomised, double blind, placebo-controlled Phase I trial is intended to test parameters such as safety and tolerability, as well as pharmacokinetics and pharmacodynamics profile of single, escalating doses of intravenously administered FDY-5301 against placebo in healthy subjects.
The trial is being conducted in Australia and is planning to enrol approximately 40 subjects.
Faraday CEO Stephen Hill said: "It is 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.
"We are working hard on our Phase II preparations in the hope of providing new options to patients as expeditiously as possible."
Data from previously held clinical studies suggested the ability of FDY-5301 to reduce reperfusion injury in both cardiac and skeletal muscle in a wide range of various animal models and in multiple species.
The company is focused on the research and development of ERAs, which have potential applications for treatment of critical care illnesses.