TABLE 1.
Noncompartmental pharmacokinetic parameter summary for tralokinumab and IgG4 in healthy volunteers receiving single intravenous infusion of 150 mg tralokinumab
| Intact tralokinumab | Total tralokinumab | Total IgG4 | ||||
|---|---|---|---|---|---|---|
| With quantifiable IgG4baseline | No quantifiable IgG4baseline | With quantifiable IgG4baseline | No quantifiable IgG4baseline | With quantifiable IgG4baseline | No quantifiable IgG4baseline | |
| n | 9 | 1 | 9 | 1 | 9 | 1 |
| Cmax (µg/ml) | 56.9 (10.8) | 54.4 | 60.2 (13.8) | 41.0 | 706 (555) | 65.0 |
| AUC a (µg × d/ml) | 81.2 (26.1) | 190 | 951 (236) | 367 | 29,900 (25,300) a | 552 a |
| CL (L/d) | 2.02 (0.67) | 0.79 | 0.166 (0.038) | 0.409 | NA | NA |
| V ss (L) | 5.35 (1.98) | 3.64 | 4.46 (0.78) | 8.26 | NA | NA |
| t 1/2 (d) | 3.93 (2.38) | 3.63 | 20.5 (2.67) | 16.6 | NA | NA |
Parameters are shown as mean (standard deviation).
Abbreviations: AUC, area under the concentration‐time curve; CL, systemic clearance; Cmax, maximum observed concentration; IgG4, immunoglobulin G4; NA, not applicable given flat terminal phase (continuous endogenous IgG4 production); n, number of subjects; t 1/2, half‐life; V ss, steady‐state volume of distribution.
a
AUC from time zero to 56 days postdose.