Table 3.
Summary of the Pharmacokinetic Parameters of Functional Dupilumab Present With Different Dupilumab Preparations and Rates of Injection
| PKM12350 | PKM14161 | PKM14271 | R668‐HV‐1108 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameter | Unit of Measurement | C2P1 300 mg Test (Formulation I, Ready to Use Glass Vials) (n = 15) | C1P2 300 mg Reference (Ready to Use Glass Vials) (n = 13) | C2P1 300 mg Test (Formulation II in Prefilled Syringe) (n = 19) | C2P1 300 mg Reference (Formulation I in Glass Vial) (n = 19) | C2P1 200 mg Test (Formulation II in Prefilled Syringe) (n = 19) | C2P1 200 mg Reference (Formulation I in Glass Vial) (n = 19) | C1P2 300 mg Fast Injection (Vial for SC Use) (n = 18) | C1P2 300 mg Slow Injection (Vial for Delivery via Syringe Pump) (n = 18) |
| Cmax, mean ± SD | mg/L | 28.9 ± 9.1 | 27.2 ± 10.0 | 34.8 ± 17.5 | 34.3 ± 11.6 | 23.2 ± 7.8 | 22.8 ± 8.9 | 34.4 ± 10.3 | 35.0 ± 14.3 |
| tmax, median (min:max) | day | 7.0 (3.0:10.0) | 7.0 (2.0:10.0) | 7.0 (3.0:14.0) | 7.0 (3.0:10.0) | 3.1 (2.9:10.0) | 3.0 (1.0:7.2) | 5.0 (3.0:20.0) | 6.9 (2.9:7.2) |
| AUClast, mean ± SD | day·mg/L | 487.5 ± 199.6 | 500 ± 179.2 | 587 ± 302 | 575 ± 235 | 339 ± 128 | 323 ± 132 | 630 ± 223 | 530 ± 233 |
AUClast indicates area under the concentration‐time curve to time of last measurable concentration; Cmax, maximum concentration in serum; C1P2, cell line 1, process 2 drug product; C2P1, cell line 2, process 1 drug product; IV, intravenous; SC, subcutaneous; and SD, standard deviation; tmax, time to Cmax.