Table 2B.
PK parameters of VIB4920 after administration of the first dose of VIB4920 and at steady state by study: Study 2
| Parameter | VIB4920 dose | ||
|---|---|---|---|
| 50 mg·kg−1 i.v. (N = 6) | 150 mg·kg−1 i.v. (N = 6) | 300 mg·kg−1 i.v. (N = 12) | |
| Tmax (days) | 0.07 (0.13) | 0.02 (0.00) | 0.05 (0.09) |
| Cmax, Day 1 (μg·ml−1) | 1,094.4 (223.4) | 3,321.2 (1,045.5) | 6,896.4 (1,542.7) |
| Ctrough, Day 8 (μg·ml−1) | 223.7 (56.2) | 576.7 (176.7) | 1,188.2 (341.7) |
| AUCDay 1–Day 8 (μg·day·ml−1) | 2,982.8 (471.3) | 7,982.3 (1,454.8) | 17,142 (3,793.7) |
| Tmax ss (days) | 0.02 (0.00) | 0.02 (0.00) | 0.05 (0.09) |
| Cmax, Day 29 (μg·ml−1) | 1,125.5 (159.6) | 4,109.6 (918.1) | 8,245.3 (1,541.2) |
| Ctrough, Day 36 (μg·ml−1) | NC | NC | 1,485.5 (225.1) |
| AUCDay 29–Day 36 (μg·day·ml−1) | NC | NC | 22,713.1 (2,461.4) |
| t 1/2 (days) | NC | NC | 6.08 (0.39) |
Note. All values are presented as mean (SD).
Abbreviations: Cmax, maximum observed concentration; Ctrough, trough concentration; i.v., intravenous; NC, not calculated; PK, pharmacokinetic; ss, steady state; Tmax, time of maximum observed concentration.