ContraVir announces FDA approval of IND, initiates clinical program of CRV431
ContraVir Pharmaceuticals announced the initiation of the clinical development program of CRV431, pursuant to the acceptance of the Investigational New Drug, or IND, application by the FDA. With the FDA's approval, ContraVir plans to begin a streamlined early clinical program of CRV431 to test the clinical safety and efficacy profile in healthy volunteers and HBV-infected patients in the United States. With an agreement of an accelerated clinical program, ContraVir plans to bridge from a single ascending dose treatment of healthy volunteers to a single dose drug-drug interaction study with Viread, tenofovir disoproxil fumarate, and ultimately into a multi-dose 28-day pilot in HBV patients. The randomized, partially-blinded, placebo-controlled study will be conducted in the United States and will consist of three parts. The first part will assess the safety, tolerability, and pharmacokinetic profile of CRV431 as it is administrated as a single dose in healthy volunteers. The second part of the study will be a single dose drug-drug interaction pilot study in stable HBV patients with CRV431 co-treated with Viread. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with Viread in stable HBV patients.