SAD stage | |||||||
---|---|---|---|---|---|---|---|
No. (%) of patients | Placebo (n=5) | 0.3 mg/kg IV (n=4) | 1.0 mg/kg IV (n=4) | 3.0 mg/kg IV (n=4) | 3.0 mg/kg SC (n=4) | 10.0 mg/kg IV (n=4) | All active (n=20) |
Study completion status | |||||||
Subjects completed study | 3 (60) | 3 (75) | 4 (100) | 2 (50) | 3 (75) | 3 (75) | 15 (75) |
Subjects discontinued early | 2 (40) | 1 (25) | 0 (0) | 2 (50) | 1 (25) | 1 (25) | 5 (25) |
Reasons for study termination | |||||||
Physician decision to withdraw subjects from study | 2 (40) | 1 (25) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (5) |
Subjects’ decision to withdraw | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (25) | 1 (20) | 2 (10) |
Adverse event | 0 (0) | 0 (0) | 0 (0) | 2 (50) | 0 (0) | 0 (0) | 2 (10) |
MD stage | ||||||
---|---|---|---|---|---|---|
No. (%) of patients | Placebo (n=5) | 0.5 mg/kg SC (n=4) | 1.5 mg/kg SC (n=5) | 3.0 mg/kg SC (n=4) | 4.0 mg/kg IV (n=5) | All Active (n=18) |
Study completion status | ||||||
Subjects completed study | 4 (80) | 3 (75) | 2 (40) | 2 (50) | 4 (80) | 11 (61) |
Subjects discontinued early | 1 (20) | 1 (25) | 3 (60) | 2 (50) | 1 (20) | 7 (39) |
Reasons for study termination | ||||||
Physician decision to withdraw subjects from study | 0 (0) | 0 (0) | 1 (20) | 1 (25) | 0 (0) | 2 (11) |
Subjects' decision to withdraw | 1 (20) | 0 (0) | 1 (20) | 1 (25) | 0 (0) | 2 (11) |
Adverse event | 0 (0) | 1 (25) | 1 (20) | 0 (0) | 1 (20) | 3 (17) |
IV, intravenous; MD, multiple dose; SAD, single ascending dose; SC, subcutaneous.