Study design and drug administration
SAD
TOLERANCE
This double-blinded, randomized, placebo-controlled phase 1a trial was comprised of three parts.The SAD study was conducted in six sequential dosing cohorts (50, 100, 200, 400, 600 or 800 mg), with a total of 62 individuals. As no PK results have been previously reported, two subjects were enrolled and administered 50 mg. Sixty subjects in the SAD study were randomly assigned to receive forsythin or placebo, with an allocation ratio of 4:1 in each dose cohort. Randomization lists for the study were created using the SAS V9.4 software (SAS Institute, Cary, NC, USA). The participants were dosed in a fasted state. Tolerance was assessed on day 4 based on a medical review of the safety results. The next dose level was administered after reviewing the safety data.In addition, 14 subjects from cohort A (A MAD study (50, 100 and 200 mg; 