Table 2

Study completion status

SAD stage
No. (%) of patientsPlacebo (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 study3 (60)3 (75)4 (100)2 (50)3 (75)3 (75)15 (75)
 Subjects discontinued early2 (40)1 (25)0 (0)2 (50)1 (25)1 (25)5 (25)
Reasons for study termination
 Physician decision to withdraw subjects from study2 (40)1 (25)0 (0)0 (0)0 (0)0 (0)1 (5)
 Subjects' decision to withdraw0 (0)0 (0)0 (0)0 (0)1 (25)1 (20)2 (10)
 Adverse event0 (0)0 (0)0 (0)2 (50)0 (0)0 (0)2 (10)
MD stage
No. (%) of patientsPlacebo (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 study4 (80)3 (75)2 (40)2 (50)4 (80)11 (61)
 Subjects discontinued early1 (20)1 (25)3 (60)2 (50)1 (20)7 (39)
Reasons for study termination
 Physician decision to withdraw subjects from study0 (0)0 (0)1 (20)1 (25)0 (0)2 (11)
 Subjects' decision to withdraw1 (20)0 (0)1 (20)1 (25)0 (0)2 (11)
 Adverse event0 (0)1 (25)1 (20)0 (0)1 (20)3 (17)
  • IV, intravenous; MD, multiple dose; SAD, single ascending dose; SC, subcutaneous.