Table 3.
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) |
NA, not applicable.