Study design
SAD) stage
RECRUITMENT
This was a randomized, double-blind, placebo-controlled phase 1 study, aiming at assessing the safety, tolerability, and PK characteristics of ibrexafungerp in healthy Chinese subjects. Two stages, the single ascending dose (SAD) stage and the multiple ascending dose (MAD) stage, were launched sequentially.This study was conducted in the Qilu Hospital of Shandong University from 3 March to 9 October 2022 in line with ethical principles derived from the Declaration of Helsinki and in compliance with the International Council for Harmonization Guidelines for Good Clinical Practice. The protocol, informed consent form (ICF), recruitment materials, all subject materials, and any amendments were submitted and approved by the Ethics Committee of Qilu Hospital of Shandong University. Written informed consent was obtained before the implementation of any study-related procedures.Eligible subjects were randomly assigned in a 6:1 ratio to receive an ibrexafungerp citrate tablet (strengths: 150 mg and 250 mg) or matching placebo (Overall design, treatments, and numbers of subjects enrolled in single-ascending dose (Eligible subjects included in this study were healthy volunteers, male or female (those who were not in pregnancy or lactating), aged between 18 and 45 years old, with a body mass index (BMI) between 19 and 27 kg/m