Table 4.

PK parameters after first dosea

Dose (mg/kg)Patients (n)Tmax (d)Cmax (μg/mL)AUC(0–7) (day·μg/mL)
0.5 QW30.04 (0.04–0.04)11.6 (5.5)9.59 (5.12)
1.5 QW30.04 (0.04–0.04)71.8 (12.5)90.8 (18.6)
5 QW30.04 (0.04–0.12)166 (37.7)431 (135)
5 QW expansion90.04 (0.04–0.30)115 (42.6)227 (99.8)
10 QW30.04 (0.04–0.14)264 (121)631 (288)
15 QW30.28 (0.12–0.30)560 (251)1950 (917)
15 QW expansion90.06 (0.04–0.30)412 (141)1280 (392)
30 Q3W30.06 (0.06–0.06)588 (213)3510 (1230)
45 Q3W30.06 (0.06–0.06)1200 (621)5790 (3390)

Abbreviations: AUC0–7, area under the concentration–time curve from time zero to 7 days; AUC0–21, area under the concentration–time curve from time 0 to 21 days; Cmax, maximum observed serum concentration; Tmax, time to maximum observed concentration.

  • aTable reflects data collected as of December 20, 2011. Parameters are presented as mean (standard deviation) except Tmax, which is presented as median (minimummaximum).