Study design
This was a double‐blind, placebo‐controlled, randomized, multicenter study with the primary objective to evaluate the safety and tolerability of single and multiple oral doses of AK0529. Secondary objectives were to evaluate the effect of AK0529 on Wang Respiratory Score, to determine the effects of treatment on viral load, and to characterize the pharmacokinetics (PK) of single and multiple AK0529 doses.The ethics committee at each trial center approved the trial. All subjects' parents or legal guardians provided written informed consent.The study consisted of two parts. In both parts, subjects were randomized in a 2:1 ratio to receive active treatment or placebo. Subjects were stratified by age (6 to 24 months in Cohorts 1 and 3, and 1 to <6 months in Cohorts 2 and 4).Part 1 was a single‐dose study with a 7‐day follow‐up. The doses administered to patients in Cohort 1 included 4, 2, and 1 mg/kg. The Safety Review Committee (SRC) reviewed PK and safety data after each of the sets of three patients, before further enrollment of subjects, and recommended 0.5 and 1 mg/kg as the doses for patients in Cohort 2.In Part 2, subjects received AK0529 or placebo over 5 days and were followed until day 14 post‐initial dose. The doses in Cohort 3 included 1 and 0.5 mg/kg bid. In Cohort 4, the doses included 2, 1 and 0.5 mg/kg bid.Details of the rationale for the dose selection, subject dosing, and safety review schemes in Parts 1 and 2 are detailed in the 