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Table 3 Pharmacokinetic parameters for MEDI-551

From: 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

MEDI-551 dose, mean (SD) n Cmax, μg/mL AUC0-last, μg•d/mL AUC0-inf, μg•d/mL CL, mL/kg/d T½, day Vss, mL/kg
0.1 mg/kg 1 2.7 13.0 16.1 6.2 6.8 53.7
0.3 mg/kg 3a 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 5b 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 4c 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 6d 227.0 (43.0) 2840.0 (260.0) 2890.0 (267.0) 3.5 (0.4) 13.5 (1.1) 71.6 (8.2)
  1. 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
  2. a n = 4 for Cmax
  3. b n = 6 for Cmax
  4. c n = 5 for t½
  5. d n = 7 for Cmax
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