Table 2. Adverse events (frequency) in healthy volunteers.
| - | Placebo N = 12 | 0.08mg/kg N = 6 | 0.4 mg/kg N = 6 | 1.2 mg/kg N = 6 | 4 mg/kg N = 6 | 8 mg/kg N = 6 | 16 mg/kg N = 6 |
|---|---|---|---|---|---|---|---|
| Subjects with any AE | 5 (41.7%) | 1 (16.7%) | 3 (50%) | 3 (50%) | 3 (50%) | 3 (50%) | 4 (66%) |
| Number of AEs | 7 | 1 | 6 | 7 | 5 | 8 | 5 |
| Mild AE | 6 (86%) | 0 | 5 (83%) | 5 (71%) | 5 (100%) | 5 (63%) | 4 (80%) |
| Moderate AE | 1 (14%) | 1 (100%) | 1 (17%) | 2 (29%) | 0 | 3 (38%) | 1 (20%) |
| ADR* | 1 (14%) | 0 | 0 | 0 | 2 (40%) | 2 (25%) | 2 (40%) |
| Kind of ADR | Headache | na | na | na | Headache, Injection site erythema | Abdominal discomfort, Flushing | Headache |
*related or possibly related ADR = adverse drug reaction; na = not applicable