Ascletis Pharma announced 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. 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.