Safety and Tolerability
No serious adverse events (SAEs) were reported. In the renal impairment group, eight subjects experienced 11 AEs, which were mild in severity. Three AEs, including a skin pruritus, an increased serum creatinine level, and a prolonged QT interval, possibly related to study treatment in three (3/10, 30%) renal impairment patients, were resolved on the same day without any intervention. Three AEs from the healthy subjects, which were considered not related to the study drug, were mild in severity and tended to be transient. No clinically relevant change in the physical examination was observed. In general, nemonoxacin was well tolerated in both the renal impairment group and healthy control group (Table 2).