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Table 3 Noncompartmental pharmacokinetic parameters

From: Dose-escalation of human anti-interferon-α receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study

Parameter MEDI-546
0.1 mg/kg single dose 0.3 mg/kg single dose 1.0 mg/kg single dose 3.0 mg/kg single dose 10.0 mg/kg single dose 20.0 mg/kg single dose 0.3 mg/kg/week multiple dose 1.0 mg/kg/week multiple dose 5.0 mg/kg/week multiple dose
1stdose 4thdose 1stdose 4thdose 1stdose 4thdose
Number of subjects 1 4 4 4 4 4 4 4 4 4 5 3
Cmax, mean (SD), μg/mL 1.97 (NA) 6.69 (1.47) 23.3 (2.22) 72.4 (13.7) 213 (44.0) 394 (83.5) 6.43 (0.470) 6.32 (1.01) 19.1 (7.80) 35.8 (15.5) 87.6 (19.3) 135 (26.5)
AUCa, mean (SD), μg · day/mL 2.45 (NA) 12.4 (4.91) 102 (14.1) 497 (105) 2610 (728) 4870 (1750) NA 10.7 (2.53) NA 159 (68.9) NA 849 (165)
CL, mean (SD), mL/kg/day 40.8 (NA) 27.4 (11.0) 9.94 (1.44) 6.26 (1.43) 4.07 (1.13) 4.67 (2.18) NA NA NA NA NA NA
t1/2, mean (SD), d 0.84 (NA) 1.24 (0.358) 2.96 (0.593) 4.07 (1.23) 7.70 (2.26) 11.8 (2.06) NA 1.06 (0.174) NA 4.94 (1.47) NA 6.28 (0.921)
  1. aAUCinf for single-dose groups and AUC0–7 for multiple-dose groups.
  2. AUCinf area under the serum concentration-time curve from zero to infinity; AUC0–7, AUC from day 0 to day 7 post dose administration; CL, systemic clearance; Cmax, maximum serum concentration; d, days; NA, not available; SD, standard deviation; t1/2, serum elimination half-life.