Table 2.
Pharmacokinetic Parameters of Risankizumab Following Single Doses of 18 mg, 90 mg, 300 mg SC in Healthy Subjects
| Risankizumab Dose | Pharmacokinetic Parameters | Units | Japanese (N = 6) | Chinese (N = 6) | White (N = 6) |
|---|---|---|---|---|---|
| 18 mg SC | Cmax | µg/mL | 1.70 (30) | 1.91 (29) | 1.04 (21) |
| Tmax a | d | 7.0 (7.0–14.0) | 7.0 (3.0–7.0) | 7.0 (3.0–28.1) | |
| t½ b | d | 32.5 (4.95) | 28.5 (3.78) | 30.5 (8.93) | |
| AUC∞ | µg·d/mL | 84.7 (17) | 77.3 (22) | 59.3 (18) | |
| 90 mg SC | Cmax | µg/mL | 9.08 (7) | 6.81 (27) | |
| Tmax a | d | 7.0 (7.0–7.0) | 5.0 (3.0–7.0) | ||
| t½ b | d | 26.9 (1.54) | 26.7 (3.73) | ||
| AUC∞ | µg·d/mL | 377 (6) | 336 (22) | ||
| 300 mg SC | Cmax | µg/mL | 22.3 (41) | 19.5 (26) | 20.4 (39) |
| Tmax a | d | 7.0 (7.0–14.0) | 7.0 (3.0–14.0) | 7.0 (3.0–7.0) | |
| t½ b | d | 29.7 (4.80) | 33.8 (7.15) | 28.7 (3.77) | |
| AUC∞ | µg·d/mL | 1100 (37) | 1030 (28) | 915 (33) |
AUC∞ indicates area under the plasma concentration‐time curve from time 0 to infinity; Cmax, maximum plasma concentration; SC, subcutaneous; t½, elimination half‐life; Tmax, time to maximum plasma concentration.
Data are presented as mean (%CV), unless noted otherwise.
a
Median (minimum through maximum).
b
Harmonic mean (pseudo‐SD); evaluations of t½ were based on statistical tests for β.