Table 4.

PK Parameter Estimates After the Last Doses of 10 or 20 mg/kg

Subject	Dose mg/kg	Doses of Otlertuzumab	Rsq adjusted	# points lambda z	HL day	Tmax day	Cmax μg/mL	Cmax/Dose kg*μg/mL/mg	AUC day*μg/mL	AUC/dose day*kg*μg/mL/mg	V mL/kg	CL mL/day/kg
1103	10	12	0.970	5	7.80	0.20	288.95	28.90	1,240	124	66.6	5.91
1104	10	12	0.865	3	10.02	0.20	264.801	26.48	1,210	121	74.9	5.18
1301	10	12	0.971	3	7.42	0.20	205.459	20.55	1,066	107	71.9	6.71
1302	10	12	0.987	4	10.71	0.20	251.469	25.15	1,361	136	70.7	4.58
1303	10	4	0.999	5	5.84	0.20	167.061	16.71	1,315	132	75.6	8.98
1901	10	12	0.943	4	10.75	0.25	353.28	35.33	1,908	191	33.3	2.14
Mean					8.76		255.17	25.52	1,350	135	65.48	5.58
SD					2.03		64.97	6.50	292	29	16.11	2.28
CV%					23.20		25.5	25.5	21.6	21.6	24.6	40.8
1105	20	5	0.996	3	11.35	0.20	586.742	29.34	2,944	147	66.7	4.07
1106	20	10	0.993	3	7.16	0.20	737.957	36.90	2,870	144	55.3	5.35
1107	20	12	1.000	3	8.51	0.20	602.977	30.15	2,753	138	67.5	5.50
1304	20	4	0.781	4	16.97	0.20	393.394	19.67	2,908	145	92.6	3.78
1402	20	6	0.955	4	8.96	0.20	777.885	38.89	3,323	166	50.0	3.87
1902	20	12	0.789	5	6.98	0.20	591.573	29.58	2,626	131	55.1	5.47
Mean					9.99		615.1	30.75	2,904	145	64.52	4.67
SD					3.76		135.8	6.79	236	12	15.40	0.85
CV%					37.69		22.1	22.1	8.1	8.1	23.9	18.1

Abbreviations: STD, Standard deviation; CV%, coefficient of variation; RSQ adjusted, Goodness of fit statistic for the terminal elimination phase adjusted for the number of points used in the estimation of λ_z; # points lambda z=number of points in the terminal elimination phase used to calculate λ_z; HL, Apparent terminal elimination half life; T_max, Time to reach C_max; C_max, Maximum observed concentration, occurring at T_max; C_max/Dose, Maximum observed concentration normalized by dose; V, Volume of distribution based on the terminal phase; CL, Systemic clearance; AUC, Area under the concentration-time curve