Table 2.
Calculated PK parameters after single IV doses of rozanolixizumab in cynomolgus monkeys. Data shown are geometric mean (coefficient of variation).
| Pharmacodynamics |
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|---|---|---|---|---|---|---|---|---|
| Plasma [IgG] |
Pharmacokinetics, mean (%CV) |
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| Format | Dose, mg/kg | n | % change from baseline | Time to nadir, days | Cmax, µg/mL | Cmax/actual dose | AUClast, µg/mL/day |
AUClast/actual dose |
| Rozanolixizumab | 0 | 4 | 0 | n/a | n/a | n/a | n/a | n/a |
| 5 | 4 | 49 | 3.5 | 84.7 (17.6%) | 4.6 (19.2%) | 56.1 (18.4%) | 3.1 (27.8%) | |
| 10 | 4 | 63 | 5 | 266.2 (4.9%) | 7.4 (16.4%) | 216.1 (12.6%) | 6.1 (20.8%) | |
| 30 | 4 | 69 | 7 | 730.5 (11.5%) | 9.1 (14.5%) | 853.7 (7.6%) | 10.7 (10.4%) | |
AUClast, area under the concentration-time course until last quantifiable concentration; Cmax, maximum observed plasma concentration; CV, coefficient of variation; IgG, immunoglobulin G; n/a, not applicable.