TABLE 1

Pharmacokinetic and pharmacodynamic parameters of anti-mCD28 dAb-001 in mice or anti-hCD28 dAb-001 in monkeys

ParameterValue Estimated (Mean ± S.D.)
MouseMonkey
PK
ka (hour−1)0.28 ± 0.0450.029 ± 0.0023
kel (hour−1)0.036 ± 0.00360.026 ± 0.0017
kpt (hour−1)0.0065 ± 0.00440.016 ± 0.0028
ktp (hour−1)0.040 ± 0.00750.022 ± 0.0026
 Vc (l/kg)0.077 ± 0.0088a0.033 ± 0.0011
 F (%)100 ± 6.1 (SC)
RO
 Emax (%)100 (fixed)100 (fixed)
 EC50 (nM)1.4 ± 0.0887.6 ± 0.60
PD (KLH-induced IgG)
kKLH (hour−1)0.0033 ± 0.00033
keffect (hour−1)2.9 ± 0.39
 τ (hour)73 ± 3.7
 Baseline IgG responsefixed at each dose levelb
  • a Vc,apparent for the mouse data.

  • b Based on the geometric mean of 4 animals at each dose group, the baseline IgG response was fixed at 42, 29, 33, and 121 for the vehicle group, 0.05, 0.5, and 5 mg/kg, respectively.