ContraVir Initiates Phase 1/2a Clinical Study of CMX157 for Treating Chronic Hepatitis B Infection

ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV) announced it has commenced screening healthy volunteers for enrollment into the Phase 1 portion of the Company’s Phase 1/2a multiple ascending dose clinical study of CMX157, ContraVir’s novel, highly potent lipid conjugate of tenofovir for treating hepatitis B virus (HBV) infection.
According to the news:

The Phase 1 portion of the study will enroll 50 healthy volunteers assigned to one of five sequential, ascending CMX157 dosing cohorts.  Participants will receive two weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157 or placebo; eight per cohort receiving CMX157 and two per cohort receiving placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of CMX157.  Initiation of each higher dose cohort will proceed following review of the data from the previous cohort. An independent review will be conducted by a data safety and monitoring board (DSMB) between the 25 mg and 50 mg cohorts (the midpoint of the Phase 1 portion of the study).

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