Table 2.
SAD Stage | MD Stage | ||||||
---|---|---|---|---|---|---|---|
No. (%) Patients | Placebo (n = 6) |
All Active (n = 24) |
Placebo (n = 7) |
1.5 mg/kg (SC) (n = 12) | 3.5 mg/kg (SC) (n = 12) | 5.0 mg/kg (IV)(n = 5) | All Active(n = 29) |
Adverse Events | |||||||
Any event | 1 (17) | 6 (25) | 0 (0) | 1 (8) | 3 (25) | 1 (20) | 5 (17) |
Nausea | 0 (0) | 2 (8) | 0 (0) | 0 (0) | 1 (8) | 0 (0) | 1 (3) |
Flank pain | 0 (0) | 2 (8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Fatigue | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 1 (8) | 0 (0) | 2 (7) |
Pruritis | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 1 (20) | 2 (7) |
Rash | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 1 (20) | 2 (7) |
Serious Adverse Events | |||||||
Any event | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
IV, intravenous; MD, multiple dose; SAD, single ascending dose; SC, subcutaneous.
*Adverse events determined by investigators to be related to MTRX1011A by preferred term in ≥ 2 patients.