Table 6 Maximum Tolerated Dose (MTD) determination for dose selection for efficacy study
Group No | 1 | 2 | 3 | 4 |
|---|---|---|---|---|
Conjugate | ACT-101-ABZ982 low DPR | ACT-101-ABZ982 high DPR | ACT-101-ABZ1827 low DPR | ACT-101-ABZ1827 high DPR |
DPR | 3.74 | 5.81 | 3.92 | 5.96 |
0 mg/kg (n = 3) | No findings | No findings | No findings | No findings |
5 mg/kg (n = 3) | No findings | No findings | No findings | No findings |
10 mg/kg (n = 3) | No findings | ↓bodyweight, ↑AST & ALT (not significant) (MTD) | Slight hemolysis (MTD) | No findings |
20 mg/kg (n = 3) | Slight hemolysis ↑AST & ALT (NS) (MTD) | ↓bodyweight, dehydration, ↓liver weight, ↑AST & ALT | ↑AST & ALT | No findings (MTD) |
40 mg/kg (n = 3) | ↓bodyweight, dehydration, ↓liver weights, ↑AST & ALT | Deaths, ↓bodyweight, rash, ↓liver weight, ↑AST & ALT | ↓bodyweight ↑AST & ALT | Deaths, ↓bodyweight, ↓liver weight, ↑AST & ALT |