Safety and tolerability
abnormal ECG T wave was 8.3% and 7.1, tolerance-related adverse reactions, TEAEs, SAD
ADVERSE REACTIONS, ADVERSE EVENT, ADVERSE EVENTS
Overall, there were 26 (41.9%), 11 (55.0%) and 5 (31.3%) subjects with one or more occurrences of treatment-emergent adverse event (TEAE) respectively in the SAD, MAD, and FE groups (Additional file All TEAEs were graded as I/II, and all subjects who completed the follow-up showed recovery or improvement. No SAE occurred, and no subjects withdrew from the trial because of adverse reactions. In this study, tolerance-related adverse reactions were only observed in the SAD group. Out of the 62 subjects included in the SS set, 3 subjects had 3 tolerance-related adverse reactions of severity grade II following ingestion of the study drug, accounting for an incidence of 4.8%.In the SAD arm, the AD16 and placebo groups exhibited about equal incidence of adverse events: 26 adverse events occurred in 19 subjects (39.6%) in the AD16 group, while 10 adverse events eventuated in 7 subjects (50.0%) in the placebo group.In the AD16 group and the placebo group, the incidence of abnormal ECG T wave was 8.3% and 7.1%, respectively, and the incidence of elevated blood triglyceride was 14.6% and 14.3%, respectively (Additional file In MAD, out of the 20 subjects included in the SS set, 15 TEAEs occurred in the 9 (56.3%) subjects from the AD16 group, and 3 TEAEs were observed in 2 subjects (50%) from the placebo group. Overall, AD16 demonstrated comparable safety to the placebo. In the AD16 group and the placebo group, the incidence of ECG Brugada wave was 6.3% and 0, respectively, and the incidence of elevated blood triglyceride was 12.5% and 25%, respectively. The incidence of TEAEs in 40 mg group was lower than that in 30 mg group (Additional file In FE, among the 16 subjects included in the SS set, 2 subjects (12.5%) from the fasting group had 2 cases of TEAEs, and 3 subjects (18.8%) in the fed state had 3 TEAEs, showing similar TEAE incidence and severity in fasting state and postprandially. In the high-fat diet group and the fasting group, the incidence of abnormal ECG T wave was 12.5% and 6.3%, respectively, and the incidence of elevated blood triglycerides was 6.3% and 0 respectively (Additional file 