Table 4.
Pharmacokinetics of mogamulizumab following the first and fourth weekly doses in phase 1
| Dose | Week | No. of patients | Mean ± standard deviation | |||||
|---|---|---|---|---|---|---|---|---|
| Tmax (h) | Cmax (ng/mL) | Ctrough (µg/mL) | AUC0-7days (µg/h per mL) | t1/2 (h) | R | |||
| 0.1 mg/kg | 1 | 3 | 2.11 ± 2.76 | 1.52 ± 0.769 | 0.436 ± 0.288 | 122 ± 758 | 130 ± 16.4 | – |
| 4 | 3 | 3.08 ± 1.73 | 2.72 ± 2.02 | 0.116* | 301 ± 254 | 350 ± 270 | 2.17 ± 1.01 | |
| 0.3 mg/kg | 1 | 3 | 2.41 ± 1.15 | 4.90 ± 0.595 | 1.91 ± 0.45 | 468 ± 97.8 | 184 ± 51.9 | – |
| 4 | 3 | 2.51 ± 1.16 | 13.6 ± 2.76 | 7.07† | 1440† | 430† | 3.05† | |
| 1.0 mg/kg | 1 | 3 | 1.74 ± 0.583 | 14.7 ± 4.78 | 4.42 ± 1.18 | 1050 ± 221 | 184 ± 64.4 | – |
| 4 | 3 | 2.54 ± 0.50 | 18.8 ± 4.14 | 8.33 ± 2.18 | 1970 ± 342 | 334 ± 84.3 | 1.88 ± 0.075 | |
R, accumulation ratio (fourth dose/first dose for AUC0-7days); Tmax, time to Cmax.
*
n = 1.
†
n = 2.