Safety and tolerability
syncope, abdominal pain, diarrhea, TEAEs, SAD
ADVERSE EVENT
All 70 subjects received at least one dose of study drug and were included in the safety analysis sets. TEAEs were reported in 8 (66.7%), 11 (91.7%), 12 (100.0%), 12 (100.0%), and 12 (100.0%) subjects in SAD and MAD stages. All TEAEs were mild to moderate in severity. There were no SAEs, severe AEs, or AEs leading to withdrawal during this study. The most common TEAEs in SAD and MAD stages was diarrhea (69.4% and 91.7%, respectively). The most common ibrexafungerp-related TEAEs were also the most common TEAEs. The comparative analysis between SAD and MAD stages showed that the incidence of diarrhea gradually increased with increasing doses. Most TEAEs were resolved without corrective interventions except for three reports (two reports of abdominal pain and one report of syncope) from three subjects in 1,500 mg cohort, who recovered after being treated with an infusion of electrolyte balance solutions and anisodamine. All ibrexafungerp-related TEAEs in SAD and MAD stages were presented in Study drug-related TEAEs in the single ascending dose (SAD) stageStudy drug-related TEAEs in the multiple ascending dose (MAD) stageNote: The percentage was calculated using the number of subjects in each cohort of the safety analysis set as the denominator. Adverse events associated with the study drug were defined as those in which the association with the study drug during administration was “definitely relevant”, “probably relevant”, or “undetermined”. Adverse events were coded based on MedDRA 25.1.