Table 1.
Dose escalation scheme
| Group | No. of subjects | Loading dose 15 min | Maintenance dose 7 h 45 min |
|---|---|---|---|
| Part A (no placebo) | |||
| (mg) | |||
| 1 | 1 | 1 | ‐ |
| 2 | 1 + 1 | 10 | ‐ |
| Part B (nangibotide 3:1 placebo) | |||
| (mg kg−1) | (mg kg−1 h−1) | ||
| 3 | 4 | 0.5 | 0.03 |
| 4 | 4 | 1.0 | 0.10 |
| 5 | 4 | 2.0 | 0.30 |
| 6 | 4 | 5.0 | 1.00 |
| 7 | 4 | 5.0 | 3.00 |
| 8 | 4 | 5.0 | 6.00 |
For Part A (groups 1 and 2), each subject received nangibotide. For Part B (groups 3–8, double‐blinded) three subjects received nangibotide and one subject received placebo (3:1 ratio). Among a total of 27 randomized subjects, 21 received nangibotide and six received placebo