Ascletis Pharma Inc. announces dosing of 24 healthy subjects of the first 3 cohorts in multiple-dose escalation Phase I clinical trial of oral RNA-dependent RNA polymerase (RdRp) inhibitor ASC10 for COVID-19 at the National Medical Center for Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University.
The multiple-dose escalation Phase I clinical trial will enroll 72 healthy subjects including 60 subjects in 6 dose escalation cohorts and 12 subjects in food effect trial. The enrollment is expected to be completed in the fourth quarter of 2022. 60 healthy subjects will be randomized into 6 cohorts to receive escalated multiple doses of ASC10 tablets of 50 mg, 100 mg, 200 mg, 400 mg, 600 mg and 800 mg twice daily (BID) or matching placebo for 5.5 days in a double-blind, placebo-controlled manner to evaluate the safety, tolerability, and pharmacokinetics (PK) of ASC10 tablets. Another 12 subjects will be randomized to receive two single 800 mg doses (fed or fasted) to evaluate the food effect on PK of ASC10 tablets in healthy subjects.
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Ascletis is China’s first biotech company which has obtained Investigational New Drug (IND) approvals of an oral RdRp inhibitor from both the U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA). On August 3, 2022, Ascletis announced that FDA had approved the IND application for ASC10 to conduct the Phase Ib clinical trial in mild-to-moderate COVID-19 patients . On August 22, 2022, Ascletis announced that China NMPA had approved the IND application of ASC10 to conduct Phase I clinical trial in healthy subjects (https://www.ascletis.com/news_detail/179/id/734.html). Ascletis is actively communicating with regulatory authorities to explore the possibility of further accelerating the clinical development of ASC10.
ASC10 is an oral double prodrug which has a new and differentiated chemical structure from the single prodrug molnupiravir. After oral administration, both ASC10 and molnupiravir are rapidly and completely converted in vivo into the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC). ASC10 was discovered and developed in-house. Ascletis has filed multiple patent applications for ASC10 and its use globally. ASC10 oral tablet formulation for the clinical study was developed with in-house proprietary technology of Ascletis.