DISCUSSION
diarrhea, abdominal pain, gastrointestinal degeneration, TEAEs, vomiting, SAD
GASTROINTESTINAL DISORDERS
This was the first study to assess the safety, tolerability, and PK of ibrexafungerp in healthy Chinese subjects. In the SAD stage, CWith respect to the safety of ibrexafungerp in healthy Chinese subjects, most TEAEs were mild to moderate, and resolved without medical interventions. The most common TEAEs in SAD and MAD stages were gastrointestinal disorders (including diarrhea, abdominal pain, and vomiting), which were similar to that in non-Asian populations. Moreover, no evidence of gastrointestinal degeneration or any significant clinical abnormalities was found in any biopsy of subjects in phase 1 studies overseas. These data indicated that the effect of ibrexafungerp on gastrointestinal mucosa was without significant functional or safety consequences and was completely reversible in humans.With access to two previous phase 1 studies overseas (FDA application review files of ibrexafungerp), the PK characteristics of ibrexafungerp could be compared between Asian and non-Asian subjects. In the present study, CIt is important to consider that the present study and phase 1 overseas studies were conducted with different populations and under different conditions, therefore, the comparison of PK parameters of ibrexafungerp should be interpreted with caution. The observed difference in AUC