AEs in subjects receiving subcutaneous injection of ACE910
AEs . | Placebo n (%) . | Dose of ACE910 (mg/kg) . | ||||
---|---|---|---|---|---|---|
0.001 n (%) . | 0.01 n (%) . | 0.1 n (%) . | 0.3 n (%) . | 1 n (%) . | ||
Japanese | ||||||
Total subjects with at least 1 AE | 2 (20.0) | 2 (33.3) | 1 (16.7) | 3 (50.0) | 0 (0.0) | 2 (33.3) |
Nasopharyngitis | 1 (10.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 1 (16.7) |
Stomatitis | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Diarrhea | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Erythema of eyelid | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pyrexia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Seasonal allergy | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Headache | 1 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
White | ||||||
Total subjects with at least 1 AE | 2 (33.3) | NA | NA | 2 (33.3) | 1 (16.7) | 2 (33.3) |
Abdominal pain upper | 0 (0.0) | NA | NA | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Diarrhea | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Bite | 0 (0.0) | NA | NA | 0 (0.0) | 1 (16.7) | 0 (0.0) |
Excoriation | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Headache | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Syncope | 0 (0.0) | NA | NA | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Bilirubin conjugated increased | 0 (0.0) | NA | NA | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Blood bilirubin increased | 0 (0.0) | NA | NA | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Nasopharyngitis | 0 (0.0) | NA | NA | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Hemorrhage subcutaneous | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
AEs . | Placebo n (%) . | Dose of ACE910 (mg/kg) . | ||||
---|---|---|---|---|---|---|
0.001 n (%) . | 0.01 n (%) . | 0.1 n (%) . | 0.3 n (%) . | 1 n (%) . | ||
Japanese | ||||||
Total subjects with at least 1 AE | 2 (20.0) | 2 (33.3) | 1 (16.7) | 3 (50.0) | 0 (0.0) | 2 (33.3) |
Nasopharyngitis | 1 (10.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 1 (16.7) |
Stomatitis | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Diarrhea | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Erythema of eyelid | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pyrexia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Seasonal allergy | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Headache | 1 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
White | ||||||
Total subjects with at least 1 AE | 2 (33.3) | NA | NA | 2 (33.3) | 1 (16.7) | 2 (33.3) |
Abdominal pain upper | 0 (0.0) | NA | NA | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Diarrhea | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Bite | 0 (0.0) | NA | NA | 0 (0.0) | 1 (16.7) | 0 (0.0) |
Excoriation | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Headache | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Syncope | 0 (0.0) | NA | NA | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Bilirubin conjugated increased | 0 (0.0) | NA | NA | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Blood bilirubin increased | 0 (0.0) | NA | NA | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Nasopharyngitis | 0 (0.0) | NA | NA | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Hemorrhage subcutaneous | 1 (16.7) | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) |
NA, not applicable.