Table 2.
Isa PK parameters observed over the first week after IV administration in Chinese patients.
| Mean ± SD [geometric mean] | Isa 20 mg/kg (n = 20) |
|---|---|
| Dose (mg/kg) | 19.8 ± 0.455 [19.8] |
| Infusion durationa (h) | 6.05 (3.85–9.47) |
| Ceoi (µg/mL) | 396 ± 106 [384] |
| Cmax (µg/mL) | 402 ± 113 [388] |
| tmaxa (h) | 7.63 (3.93–46.7) |
| Clast (µg/mL) | 132 ± 59.8 [113] |
| tlasta (h) | 167 (144–195) |
| AUCtau (µg·h/mL) | 37 000 ± 12 000 [35 100] |
aMedian (min–max) values.
AUCtau, area under the curve of plasma concentrations versus time over the dosing interval of 0–168 h; Ceoi, concentration observed at the end of IV infusion; Clast, last observed concentration above the LLOQ (5 µg/mL); Cmax, maximum observed concentration; h, hours; Isa, isatuximab; IV, intravenous; LLOQ, lower limit of quantitation; SD, standard deviation; Tlast, time to last concentration observed above the LLOQ; Tmax, time to reach Cmax.