Table 3.
Summary of samalizumab PK parameters
| Dose | No. of patients | Tmax (h) |
Cmax (μg/mL) |
AUC∞ (μg·h/mL) |
T1/2 (h) |
CL (mL/h) |
Vz (mL) |
|
|---|---|---|---|---|---|---|---|---|
| 100 mg/m2 | 5 | 2.21 ± 3.25 | 38.9 ± 4.75 | 2792 ± 2227 | 85.1 ± 60.9 | 101 ± 67.5 | 8246 ± 1499 | |
| 200 mg/m2 | 3 | 1.23 ± 0.09 | 90.2 ± 10.6 | 11,957 ± 6599 | 107 ± 45.2 | 36.3 ± 14.9 | 4943 ± 469 | |
| 300 mg/m2 | 3 | 4.71 ± 4.65 | 109 ± 42.7 | 36,636 ± 11,540 | 371 ± 48.9 | 16.9 ± 4.15 | 9186 ± 3215 | |
| 400 mg/m2 | 3 | 8.93 ± 11.1 | 135 ± 37.8 | 37,679 ± 7219 | 245 ± 33.9 | 21.3 ± 4.61 | 7391 ± 897 | |
| 500 mg/m2 | 7 | 3.87 ± 1.85 | 211 ± 44.9 | 62,898 ± 24,222 | 365 ± 172 | 19.5 ± 10.4 | 8490 ± 1715 | |
| 600 mg/m2 | 1 | 3.08 | 288 | 134,629 | 538 | 7.58 | 5880 |
Values are presented as Mean ± SD. The samalizumab serum concentration assay had a lower limit of quantification of 3.70 μg/mL and the standard curve ranged from 3.7 to 100 μg/mL Assay precision was 1 to 18% and accuracy was 93.2 to 127.8% (Mean % of recovery)