GTx Second SARM Shows Phase I Clinical Safety
GTx, a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for serious men's health conditions and oncology, has completed a Phase I clinical trial of ostarine, the company's second selective androgen receptor modulator (SARM) clinical product candidate.
The Phase I clinical trial evaluated the safety, tolerability and pharmacokinetic profile of ostarine using a single ascending dose, double-blind, placebo-controlled design in 96 healthy volunteers.
Results of the Phase I clinical trial indicated that ostarine appears to be safe and was well-tolerated. There were no serious dose-related or clinically significant adverse events observed in the clinical trial. GTx plans to initiate a multiple ascending dose Phase I clinical trial of ostarine in April 2005.