Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, announced today that it has dosed the first subject in a Phase I clinical trial of TKM-HBV, a therapeutic agent designed to reduce hepatitis B surface antigen in patients chronically infected with hepatitis B virus (HBV).
"We are pleased to have reached this important milestone, initiation of phase I studies with TKM-HBV. Since TKM-HBV represents our most important development program, we are testing two LNP formulations, generations three and four, of the product in this study. We expect the results to determine which product formulation we will advance into chronically infected patients later this year," said Dr. Mark J. Murray, Tekmira's President and CEO.
The TKM-HBV Phase I clinical trial is a randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV. The study will assess the safety, tolerability and pharmacokinetics of intravenous administration of two formulations of TKM-HBV in healthy adult subjects. For each formulation, there are five planned cohorts for a total of 20 subjects (40 in total for both formulations). Four subjects will be enrolled per cohort with three subjects receiving TKM-HBV, and one receiving placebo.