BioCentury
ARTICLE | Clinical News

CTP-354: Phase I ongoing

July 21, 2014 7:00 AM UTC

Concert said that FDA lifted a partial clinical hold on CTP-354 after the company completed preclinical toxicology studies testing repeated doses of CTP-354 greater than 6 mg/day. The agency placed the hold in November, preventing Concert from administering single doses >60 mg/day and multiple doses >6 mg/day in clinical trials without first conducting a preclinical study of an additional higher dose. ...