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July 23, 2013
07:38 EDTARWRArrowHead begins phase 1 trial of ARC-520 for Hepatitis B infection treatment
Arrowhead Research announced that it has initiated dosing in a Phase 1 clinical trial of ARC-520, the company’s candidate for the treatment of chronic hepatitis B virus infection. Trial initiation followed successful completion of the Clinical Trial Notification regulatory process in Australia. The objectives of the study are to characterize the safety profile of ARC-520, determine maximum tolerated dose, and evaluate pharmacokinetics in healthy volunteers.The Phase 1 trial is a single-center, randomized, double-blind, placebo-controlled, single dose-escalation, first-in-human study of ARC-520 administered intravenously to healthy adult volunteers and is being conducted in Melbourne, Australia. Each dose cohort includes 6 subjects randomized at ratio of 1:2 to receive a single intravenous injection of either placebo or ARC-520. Arrowhead expects to complete this Phase 1 trial in Q4 and begin a Phase 2a trial in chronic HBV patients in 2014.
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