Table 1 Study schema for single-dose and multiple-dose escalation stagesa
Stage dose and route | Patients, n(active:placebo) |
|---|---|
SAD stage dose, route (cohort) | |
0.3 IV (A) | 4:1 |
1.0 IV (B) | 4:1 |
1.0 SC (C) | 4:1 |
3.0 IV (D) | 4:1 |
3.0 SC (E) | 4:1 |
5.0 IV (F) | 4:1 |
MAD stage dose, route (cohort) | |
1.0 SC (G) | 8:2 |
3.0 SC (H) | 16:4 |
5.0 IV (I) | 4:1 |