Table 3.
Study design and mean PK parameters of rozanolixizumab in the 13-week toxicity study in cynomolgus monkeys. Data shown are arithmetic mean (SD).
| Dosing regimen | Number of males/females | Necropsy at Day 91 | Necropsy at Day 144 | Cmax (µg/mL), mean (SD) |
AUC0–τ (µg/mL/day), mean (SD) |
||
|---|---|---|---|---|---|---|---|
| Day 1 | Day 64 or 88 | Day 1 | Day 64 or 88 | ||||
| Vehicle control | 6M/6F* | 3M/3F | 2M/2F | – | – | – | – |
| 50 mg/kg SC q3 days | 4M/4F | 4M/4F | n/a | 404 (84.2) |
157 (192) |
828 (244) |
327 (408) |
| 150 mg/kg SC q3 days | 6M/6F* | 4M/4F | 2M/2F | 1780 (639) |
1730 (998) |
3740 (1130) |
3780 (2290) |
| 150 mg/kg SC q3 days (Weeks 1, 6, 10) |
6M/6F* | 4M/4F | 2M/2F | 1700 (338) |
1160 (503) |
3570 (569) |
2410 (1220) |
| 150 mg/kg IV q3 days | 6M/6F* | 4M/4F | 2M/2F | 4230 (618) |
4870 (1030) |
5450 (841) |
5370 (2230) |
*includes 2M + 2F for recovery
AUC0–τ, area under the plasma concentration (for repeated dosing) versus time curve on Day 1 or Day 64 or 88; Cmax, maximum observed plasma concentration; D, day; F, female; M, male; W, week.