Table 2.
Serum PK parameters of nipocalimab
| 15 mg/kg (n = 10) | 30 mg/kg (n = 10)b | 45 mg/kg (n = 10)b | |
|---|---|---|---|
| Cmax, μg/mL | 337 (31) | 814 (97) | 1172 (115) |
| Tmaxa, h | 0.8 (0.5–1.5) | 0.5 (0.5–2.5) | 0.6 (0.5–2.5) |
| Clast, μg/mL | 2.42 (4.70) | 0.02 (0.01) | 0.14 (0.35) |
| Tlasta, h |
180.6 (144.4–337.2) |
263.9 (263.6–672.5) |
336.1 (264.0–336.4) |
| AUClast, μg h/mL | 17,505 (2345) | 58,784 (7934) | 91,738 (9344) |
| AUC∞, μg h/mL | 17,574 (2404) | 60,220 (6901) | 92,963 (9023) |
| t1/2, h | 14.3 (5.0) | 9.3 (3.4) | 14.1 (8.6) |
| Vz, L | 1.1 (0.4) | 0.5 (0.2) | 0.7 (0.5) |
| CL, L/h | 0.055 (0.006) | 0.036 (0.005) | 0.032 (0.004) |
Data are mean (standard deviation) unless otherwise specified
aData are median (range)
bn = 9 for AUC∞, t1/2, Vz, and CL
AUCinf AUC from time 0 extrapolated to infinity, AUClast area under the serum concentration–time curve from start of infusion at time 0 to the time of the last measurable concentration, CL clearance, Clast last measurable serum concentration, Cmax maximum observed serum concentration, PK pharmacokinetics, t1/2 half-life, Tlast time of last measurable serum concentration, Tmax time to reach the maximum observed serum concentration, Vz volume of distribution