Table 2.
Events, n (%) | Placebo (N = 6) | Kukoamine B | |||
---|---|---|---|---|---|
0.06 mg/kg (N = 6) | 0.12 mg/kg (N = 6) | 0.24 mg/kg (N = 6) | All (N = 18) | ||
With any AE, n (%) | 4 (66.67%) | 4 (66.67%) | 3 (50%) | 5 (83.33%) | 12 (66.67%) |
With any TRAE, n (%) | 2 (33.33%) | 2 (33.33%) | 1 (16.67%) | 5 (83.33%) | 8 (44.44%) |
AE, n (%) | |||||
Investigations | 0 (0%) | 0 (0%) | 0 (0%) | 4 (66.67%) | 4 (22.22%) |
γ-Glutamyl transferase increased | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Alanine aminotransferase increased | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Blood alkaline phosphatase increased | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Aspartate aminotransferase increased | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Metabolism and nutrition disorders | 2 (33.33%) | 2 (33.33%) | 1 (16.67%) | 3 (50%) | 6 (33.33%) |
Hypocalcemia | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Hypertriglyceridemia | 2 (33.33%) | 2 (33.33%) | 1 (16.67%) | 1 (16.67%) | 4 (22.22%) |
Hypokalemia | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Skin and subcutaneous tissue disorders | 1 (16.67%) | 1 (16.67%) | 1 (16.67%) | 0 (0%) | 2 (11.11%) |
Skin exfoliation | 1 (16.67%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Rash maculopapular | 0 (0%) | 1 (16.67%) | 0 (0%) | 0 (0%) | 1 (5.56%) |
Pruritus | 0 (0%) | 0 (0%) | 1 (16.67%) | 0 (0%) | 1 (5.56%) |
Gastrointestinal disorders | 0 (0%) | 0 (0%) | 0 (0%) | 2 (33.33%) | 2 (11.11%) |
Gingival pain | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Mouth ulcer | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Renal and urinary disorders | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Proteinuria | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.67%) | 1 (5.56%) |
Blood and lymphatic system disorders | 0 (0%) | 1 (16.67%) | 0 (0%) | 0 (0%) | 1 (5.56%) |
Anemia | 0 (0%) | 1 (16.67%) | 0 (0%) | 0 (0%) | 1 (5.56%) |
Nervous system disorders | 1 (16.67%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Orthostatic hypotension | 1 (16.67%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Cardiac disorders | 0 (0%) | 2 (33.33%) | 1 (16.67%) | 0 (0%) | 3 (16.67%) |
Sinus bradycardia | 0 (0%) | 2 (33.33%) | 1 (16.67%) | 0 (0%) | 3 (16.67%) |
AE adverse event, TRAE treatment-related adverse event