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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 |
aIV = intravenously; MAD = multiple ascending doses; SAD = single ascending dose; SC = subcutaneously.
