Table 2 Pharmacokinetic data of vilobelimab and C5a [ng/mL]
Visit statistic | Vilobelimab concentration | C5a concentration | ||
|---|---|---|---|---|
Absolute value | Absolute value | |||
Vilo + SOC (N = 96) | Placebo + SOC (N = 101) | Vilo + SOC (N = 96) | Placebo + SOC (N = 101) | |
Screening | ||||
n | 93 | 99 | 94 | 99 |
Mean (SD) | 0.00 (0.00) | 0.00 (0.00) | 130.25 (71.45) | 123.15 (65.53) |
Geom. Mean | n.a | n.a | 112.83 | 106.95 |
Day 8 | ||||
n | 81 | 91 | 82 | 91 |
Mean (SD) | 151,236.35 (56,782.86) | 0.00 (0.00) | 16.80 (9.15) | 129.81 (67.59) |
Geom. Mean | 137,881.29 | n.a | 14.54 | 116.03 |
HD Day 1–10 | ||||
n | 3 | 1 | 3 | 1 |
Mean (SD) | 198,506.84 (87,412.05) | 0.00 () | 9.06 (4.32) | 87.70 () |
Geom. Mean | 185,361.06 | n.a | 8.29 | 87.70 |
HD Day 11–20 | ||||
n | 11 | 11 | 11 | 11 |
Mean (SD) | 144,856.82 (69,976.35) | 0.00 (0.00) | 13.13 (6.30) | 99.93 (39.06) |
Geom. Mean | 130,591.95 | n.a | 11.74 | 93.00 |
HD Day 21–30 | ||||
n | 10 | 5 | 10 | 5 |
Mean (SD) | 121,030.00 (83,574.67) | 0.00 (0.00) | 23.82 (26.19) | 113.20 (46.22) |
Geom. Mean | 91,085.66 | n.a | 17.23 | 103.59 |
HD Day 31–40 | ||||
n | 4 | 6 | 4 | 6 |
Mean (SD) | 45,638.49 (73,828.83) | 0.00 (0.00) | 68.37 (49.74) | 108.75 (56.91) |
Geom. Mean | 16,579.17 | n.a | 54.65 | 93.57 |
HD after Day 40 | ||||
n | 3 | 4 | 3 | 4 |
Mean (SD) | 1235.72 (1552.04) | 0.00 (0.00) | 88.99 (13.82) | 75.27 (29.67) |
Geom. Mean | 493.34 | n.a | 88.28 | 70.89 |