TABLE 9

PK parameter estimates following a single dose of mAb A in cynomolgus monkeys from the subcolony with pre-existing ADA

DoseAnimal IDCmaxTmaxaAUCinfVzCLt1/2
μg/mldaysμg·day/mlml/kgml/day/kgdays
1 mg/kg i.v.705539b13.65187.62107.925.3314.04
70654121.94N.D.N.D.N.D.N.D.
70654919.94N.D.N.D.N.D.N.D.
707625b25.15181.6778.065.509.83
3 mg/kg i.v.705609b56.22456.8596.486.5710.18
70653358.47N.D.N.D.N.D.N.D.
706545b55.45456.58105.316.5711.11
70656556.72N.D.N.D.N.D.N.D.
10 mg/kg i.v.706605239.97N.D.N.D.N.D.N.D.
707629223.84N.D.N.D.N.D.N.D.
709599184.94N.D.N.D.N.D.N.D.
3 mg/kg s.c.70653526.403.00N.D.N.D.
706559b31.073.00772.6617.79
706575b23.853.00499.1912.22
  • N.D., not determined due to poorly defined terminal phase.

  • a Median instead of mean ± S.D. is presented for the Tmax.

  • b The individual animal tested negative for ADAs to mAb A at the end of the study.