TABLE 6

PK parameter estimates (mean ± S.D.) following a single intravenous dose of mAb A in cynomolgus monkeys from the subcolony without pre-existing ADA

DoseNCmaxAUCinfDNAUCaVzCLt1/2
μg/mlμg·day/mlμg·day/ml/mg/kgml/kgml/day/kgdays
1 mg/kg i.v.423.0 ± 4.66195 ± 19.5195 ± 19.591.3 ± 8.435.16 ± 0.5112.4 ± 1.66
3 mg/kg i.v.4b76.5 ± 2.66675 ± 54.9225 ± 18.390.9 ± 0.954.46 ± 0.3714.2 ± 1.17
10 mg/kg i.v.4219 ± 14.92676 ± 731268 ± 73.286.1 ± 15.43.99 ± 1.2415.6 ± 3.63
5 mg/kg i.v.c3116 ± 14.61127 ± 240225 ± 47.9111 ± 31.94.59 ± 1.0916.7 ± 0.82

  • ↵a DNAUC, dose-normalized AUC.

  • ↵b N = 3 for the PK parameters except for the Cmax.

  • ↵c Data obtained from a different study using naïve animals.