Study design
This study was a single-center, randomized, double-blind, placebo-controlled, dose escalation phase I clinical trial. A total of 70 subjects were enrolled. As shown in Study design of a phase I clinic trial of contezolid acefosamil in healthy Chinese subjects. IV, intravenous.The sample size was not based on a formal power calculation. According to the Technical Guidelines for Clinical Pharmacokinetic Research of Chemical Drugs issued by the National Medical Products Administration of China, 8–12 subjects are recommended in each dose cohort for a single- or multiple-dose PK study. An independent statistician performed block randomization, and the random allocation sequences were included in a randomisation envelope according to which the subjects in each dose cohort were allocated. The subjects in each dose cohort were randomised in a ratio of 3:1, 4:1, or 5:1 to receive contezolid acefosamil or placebo.The first and last doses were administered under fasted conditions (fasted ≥12 h) in all oral cohorts. If ≥1/2 of the subjects in a dose cohort experienced study drug-related grade 2 AEs or ≥1 subject experienced study drug-related grade 3 AEs, the study would be terminated, and the dose would not be further escalated.