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Arrowhead Pharmaceuticals Initiates Phase 1/2 Single and Multiple Dose Study of Hepatitis B Candidate ARC-521

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Additional Information

Additional Relevant Details The ARC-521 study (ARC5211001) is a multicenter, placebo-controlled, double-blind, dose escalation study of ARC-521 in healthy volunteers including a sequential, multiple dose, open label part in patients with chronic HBV. Normal healthy volunteers will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 or placebo. Chronic HBV patients that are negative for Hepatitis B e-antigen (HBeAg) at screening will enroll sequentially into 3 dose levels (8 patients per dose level) to receive 3 monthly doses of open label ARC-521. The study is currently recruiting at a single center in New Zealand and the company plans to add additional centers in other countries, pending regulatory and ethics review.
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Occurred on:
Jun 09, 2016
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Related Keywords Hepatitis B, Arc-521, Chronic Hbv, Hbv, Hepatitis B Virus