Table 3.
Summary of the pharmacokinetic parameters after a single 45-mg subcutaneous administration of the test drug BAT2206 and reference drug ustekinumab (EU licensed or USA licensed)
| Parameter (unit) | BAT2206 (n = 90) | Ustekinumab (EU) (n = 88) | Ustekinumab (USA) (n = 88 or 90a) |
|---|---|---|---|
| Cmax (µg/mL) | 5.6 ±1.7 (30.5) | 5.7 ± 1.6 (27.6) | 5.8 ± 1.5 (26.6) |
| AUC0–inf (h* µg/mL) | 4629 ± 1255 (27.1) | 4716 ± 1344 (28.5) | 4571 ± 1156 (25.3) |
| AUC0–t (h* µg/mL) | 4500 ± 1195 (26.6) | 4578 ± 1207 (26.4) | 4403 ± 1168 (26.5) |
| AUC0–672h (h* µg/mL) | 2657 ± 664 (25.0) | 2693 ± 617 (22.9) | 2684 ± 617 (23.0) |
| Tmax (h) | 147 (48, 337) | 144 (96, 337) | 168 (12.0, 336) |
| t1/2 (h) | 459 ± 94 (20.5) | 470 ± 104 (22.1) | 444 ± 98.4 (22.2) |
| λz (1/h) | 0.0016 ± 0.0003 (20.7) | 0.0016 ± 0.0004 (23.5) | 0.0017 ± 0.0005 (30.5) |
| CL/F (mL/h) | 10.5 ± 3.1 (29.5) | 10.2 ± 2.6 (25.8) | 10.5 ± 2.8 (26.8) |
| Vz/F (mL) | 6755 ± 1780 (26.3) | 6684 ± 1407 (21.1) | 6566 ± 1659 (25.3) |
Data are shown as mean ± standard deviation (% coefficient of variation), except Tmax and t1/2, which are median (minimum–maximum)
AUC0–inf area under the plasma concentration–time curve from time zero to infinity, AUC0–672h area under the plasma concentration–time curve from time zero to 672 hours, AUC0–t area under the plasma concentration–time curve over the dosing interval, CL/F apparent clearance, Cmax maximum plasma concentration, EU European Union, t1/2 elimination half-life, Tmax time to maximum plasma concentration, λz apparent terminal elimination rate constant, Vz/F apparent volume of distribution
aCmax, AUC0–t, AUC0–672h, and Tmax contain data from 90 subjects, and other parameters contain data from 88 subjects