Ascletis gets US FDA approval to conduct phase IIa trial of ASC10 to treat respiratory syncytial virus infection
Ascletis Pharma Inc., an innovative R&D driven biotech company, announces that the US Food and Drug Administration (FDA) has approved to conduct a phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection. Based on available data, dosage of 800 mg ASC10, twice daily was selected to conduct a randomized, double-blind, placebo-controlled phase IIa study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of ASC10 tablets in patients with mild or moderate RSV infection. ASC10 is an oral double prodrug. After oral administration, ASC10 is rapidly and completely converted in vivo into the active metabolite ASC10-A, also known as
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