Subject demographics and disposition
| Characteristic . | Dose group . | |||
|---|---|---|---|---|
| 1, 5, 12.5, and 25 IU/kg (n = 1/dose) . | 50 IU/kg (n = 5) . | 100 IU/kg (n = 5) . | Total (n = 14) . | |
| Mean age, y, (min-max) | 36.5 (21-64) | 43.4 (18-76) | 30.8 (20-55) | 36.9 (18-76) |
| Mean weight, kg (min-max) | 93.0 (78-119) | 70.2 (55-86) | 93.4 (69-130) | 85.0 (55-130) |
| Race | ||||
| White, n | 4 | 3 | 4 | 11 |
| Black, n | 0 | 1 | 1 | 2 |
| Asian, n | 0 | 1 | 0 | 1 |
| Enrolled, n | 5 | 5 | 5 | 15 |
| Evaluated for safety, n | 4 | 5 | 5 | 14 |
| Included in PK analysis, n | 2 | 5 | 5 | 12 |
| Completed, n | 4 | 5 | 5 | 14 |
| Discontinued (lost to follow-up), n | 1 | 0 | 0 | 1 |
| Characteristic . | Dose group . | |||
|---|---|---|---|---|
| 1, 5, 12.5, and 25 IU/kg (n = 1/dose) . | 50 IU/kg (n = 5) . | 100 IU/kg (n = 5) . | Total (n = 14) . | |
| Mean age, y, (min-max) | 36.5 (21-64) | 43.4 (18-76) | 30.8 (20-55) | 36.9 (18-76) |
| Mean weight, kg (min-max) | 93.0 (78-119) | 70.2 (55-86) | 93.4 (69-130) | 85.0 (55-130) |
| Race | ||||
| White, n | 4 | 3 | 4 | 11 |
| Black, n | 0 | 1 | 1 | 2 |
| Asian, n | 0 | 1 | 0 | 1 |
| Enrolled, n | 5 | 5 | 5 | 15 |
| Evaluated for safety, n | 4 | 5 | 5 | 14 |
| Included in PK analysis, n | 2 | 5 | 5 | 12 |
| Completed, n | 4 | 5 | 5 | 14 |
| Discontinued (lost to follow-up), n | 1 | 0 | 0 | 1 |
Min indicates minimum; and max, maximum.