Table 5.

Mean PK parameters for MORAb-004-001 in humans in cycle 1 days 1 and 22

CmaxAUC0–tt1/2
Dose (mg/kg)Cycle dayNumberμg/mL (SD) (n)μg·h/mL (SD) (n)h (SD) (n)
0.0625 mg/kgC01D0120.495 (0.177)10.8 (1.88)23.09 (–)
0.0625 mg/kgC01D2220.500 (0.141)11.6 (0.403)44.97 (–)
0.125 mg/kgC01D0120.960 (0.523)24.9 (14.2)30.7 (10.7)
0.125 mg/kgC01D2220.840 (0.721)20.7 (19.5)25.2 (0.177)
0.25 mg/kgC01D0124.50 (1.51)148 (74.7)24.74 (1.74)
0.25 mg/kgC01D2223.91 (0.898)141 (70.9)21.0 (10.2)
0.5 mg/kgC01D01411.9 (4.90)351 (144)26.19 (2.42)
0.5 mg/kgC01D22311.0 (2.15)442 (152)29.46 (3.68)
1 mg/kgC01D01423.0 (4.06)1289 (306)37.79 (8.47)
1 mg/kgC01D22324.3 (2.78)1390 (349)52.25 (17.2)
2 mg/kgC01D01346.8 (5.87)2702 (481)52.35 (18.7)
2 mg/kgC01D22350.1 (7.30)3739 (1595)83.81 (25.3)
4 mg/kgC01D013108 (4.58)7971 (597)87.12 (12.21)
4 mg/kgC01D223160 (8.49)14205 (1783)103.93 (3.84)
8 mg/kgC01D013200 (22.3)15636 (975)106.18 (10.6)
8 mg/kgC01D223280 (58.4)22908 (723)163.55 (54.7)
12 mg/kgC01D018317 (68.1)24951 (3968)119.08 (24.7)
12 mg/kgC01D226587 (91.2)64542 (15061)197.17 (41.2)
16 mg/kgC01D015447 (145)31244 (12700)120.24 (13.1)
16 mg/kgC01D223685 (169)83697 (27846)178.40 (22.4)

Abbreviations: C01D01, cycle 1 day 1; C01D22, cycle 1 day 22; SD, standard deviation.