Table 3.
Geometric mean (mean, %CV) of risankizumab plasma pharmacokinetic parameters following single IV doses ranging from 0.01 to 5 mg/kg, and single SC doses of 0.25 or 1 mg/kg in subjects with moderate-to-severe psoriasis (Study 2)
| Parameter | Unit | IV dose of risankizumab | SC dose of risankizumab | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.01 mg/kg | 0.05 mg/kg | 0.25 mg/kg | 1 mg/kg | 3 mg/kg | 5 mg/kg | 0.25 mg/kg | 1.0 mg/kg | ||
| [n = 3] | [n = 3] | [n = 3] | [n = 3] | [n = 3] | [n = 3] | [n = 6] | [n = 7] | ||
| Cmax | µg/mL | 0.311 (0.311, 9) | 1.36 (1.4, 27) | 5.95 (5.97, 11) | 12.3 (16.9, 71) | 66.2 (66.4, 9) | 110 (110, 9) | 0.886 (0.972, 47) | 4.76 (5.20, 35) |
| Tmaxa | day | 0.083 (0.067–0.083) | 0.043 (0.042–0.083) | 0.094 (0.083–0.17) | 0.042 (0.042–0.17) | 0.083 (0.042–0.083) | 0.083 (0.042–0.083) | 13.5 (7.00–14.1) | 3.00 (2.00–10.0) |
| AUC∞ | µg day/mL | 2.93 (2.99, 25) | 15.7 (17.0, 43) | 85.1 (85.6, 13) | 167 (224, 68) | 952 (955, 9) | 1650 (1680, 23) | 40.4 (44.8, 46) | 177 (201, 45) |
| t½ | day | 19.4 (19.6, 17) | 22.5 (22.8, 20) | 22.0 (22.8, 30) | 27.7 (27.8, 12) | 17.9 (19.0, 38) | 22.8 (23.7, 34) | 23.0 (24.3, 33) | 26.1 (26.5, 19) |
| CL or CL/Fb | L/day | 0.325 (0.346, 42) | 0.328 (0.347, 44) | 0.280 (0.282, 16) | 0.557 (0.829, 110) | 0.273 (0.273, 2) | 0.231 (0.237, 30) | 0.534 (0.612, 57) | 0.367 (0.390, 35) |
| AUC∞/dose | µg day/mL/mg | 3.08 (3.28, 43) | 3.05 (3.21, 35) | 3.57 (3.60, 16) | 1.79 (2.38, 67) | 3.67 (3.67, 2) | 4.34 (4.44, 25) | 1.87 (2.15, 58) | 2.73 (2.92, 43) |
Values in parentheses denote mean, %CV
AUC∞ area under the plasma concentration–time curve over the time interval from time zero to infinity, CL clearance, CL/F apparent clearance, Cmax maximal plasma concentration, %CV percentage coefficient of variation, Tmax time to achieve maximum plasma concentration, t½ terminal elimination half-life, IV intravenous, SC subcutaneous
aMedian (minimum–maximum)
bCL for IV doses, and CL/F for SC doses