TABLE 3

Pharmacokinetic parameters for the FST-ΔHBS-Fc sialic acid variants in Cynomolgus monkeys after a single 1 mg/kg intravenous administration.

Serum concentrations were determined using validated antigen capture ELISAs. Data are the mean ± S.D. of the PK parameters determined from three monkeys per group. Pharmacokinetic parameters were determined from a linear/log trapezoidal non-compartmental analysis model based on the statistical moment theory. Pairwise Tukey-Kramer analysis of mean clearance values indicates that only MV9 16% SA variant was significantly different from other variants tested (P < 0.05). Pairwise Tukey-Kramer analysis of mean half-life values indicates no significant difference in any of the variants tested (P > 0.05).

FST-ΔHBS-Fc VariantCmaxAUC0–lastCLVsst1/2
μg/mlμg•h/mlml/h/kgml/kgh
MV9 16% SA19.2 ± 1.0139 ± 347.5 ± 2.2962 ± 113178 ± 51
MV9 27% SA16.5 ± 6.7324 ± 323.0 ± 0.4481 ± 97188 ± 74
MV9 33% SA21.4 ± 1.8347 ± 622.9 ± 0.7402 ± 169141 ± 64
MV9 60% SA43.9 ± 5.01070 ± 1741.0 ± 0.251 ± 0.198 ± 38
  • AUC0–last, area under the serum concentration curve from 0 to last concentration versus time point; CL, clearance; Cmax, maximal observed serum concentration; t1/2, elimination half-life; Vss, volume of distribution at steady state.