Table 2C.
PK parameters of VIB4920 after administration of the first dose of VIB4920 and at steady state by study: Study 3
| Parameter | VIB4920 dose | |||
|---|---|---|---|---|
| 125 mg·kg−1 s.c. (N = 12) | 250 mg·kg−1 s.c. (N = 12) | 150 mg·kg−1 i.v. (N = 12) | 300 mg·kg−1 i.v. (N = 12) | |
| Tmax (days)a | 3.0 (1.0 to 3.0) | 3.0 (1.0 to 3.0) | 0.02 (0.02 to 0.02) | 0.02 (0.02 to 0.02) |
| Cmax, Day 1 (μg·ml−1) | 870 (209) | 1,590 (241) | 3,330 (520) | 7,250 (1,680) |
| AUC0–t (μg·day·ml−1) | 4,600 (864) | 8,600 (1,370) | 8,830 (776) | 17,200 (3,610) |
| Tmax Day 190 (days)a | 1.00 (0.50 to 1.00) | 1.00 (0.50 to 3.00) | 0.02 (0.02 to 0.02) | 0.02 (0.02 to 0.35) |
| Cmax, Day 190 (μg·ml−1) | 1,590 (297) | 2,870 (481) | 4,640 (696) | 7,920 (1,590) |
| AUC0–t, Day 190 (μg·day·ml−1) | 10,300 (15,800) | 23,500 (25,500) | 21,800 (20,200) | 35,900 (35,600) |
| CL (ml·day−1·kg−1) | NC | NC | 11.1 (1.2) | 12.7 (3.2) |
| t 1/2 (days) | 6.02 (ID) | 5.20 (1.37) | 5.66 (0.30) | 5.96 (0.48) |
Note. All values are presented as mean (SD) unless stated otherwise.
a
Median (range).
Abbreviations: CL, systemic clearance; Cmax, maximum observed concentration; i.v., intravenous; NC, not calculated; PK, pharmacokinetic; s.c., subcutaneous; Tmax, time of maximum observed concentration.