Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study

Table 3 Pharmacokinetic parameters for MEDI-551

MEDI-551 dose, mean (SD)	n	C_max, μg/mL	AUC_0-last, μg•d/mL	AUC_0-inf, μg•d/mL	CL, mL/kg/d	T_½, day	V_ss, mL/kg
0.1 mg/kg	1	2.7	13.0	16.1	6.2	6.8	53.7
0.3 mg/kg	3^a	8.0 (1.8)	45.7 (12.9)	50.6 (13.2)	6.2 (1.5)	7.1 (1.8)	58.9 (24.5)
1.0 mg/kg	5^b	22.5 (7.1)	202.0 (79.2)	211.0 (77.0)	5.3 (2.2)	11.3 (3.7)	69.3 (11.4)
3.0 mg/kg	4^c	83.6 (10.6)	781.0 (230.0)	789.0 (230.0)	4.1 (1.3)	11.3 (1.0)	63.4 (22.4)
10.0 mg/kg	6^d	227.0 (43.0)	2840.0 (260.0)	2890.0 (267.0)	3.5 (0.4)	13.5 (1.1)	71.6 (8.2)

AUC _0-inf area under the concentration-time curve extrapolated to infinity after dosing, AUC _0-last area under the concentration-time curve from dosing to last measurable time point, CL systemic clearance, C _max maximum observed concentration, t _½ terminal elimination half-life, V _ss steady-state volume of distribution
^a n = 4 for C_max
^b n = 6 for C_max
^c n = 5 for t_½
^d n = 7 for C_max

ISSN: 1478-6362