TABLE 4.
Summary of PK parameters for anti-PA IgG concentration in PK population
| PK parametera | Results (mean [SD]) by AVP-21D9 dose (mg/kg) group: |
|||
|---|---|---|---|---|
| 0.3 (n = 8) | 1 (n = 8) | 3 (n = 12) | 10 (n = 12) | |
| AUC0-∞ (days · μg/ml) | 158.8 (122.76) | 376.4 (99.56) | 1,045.0 (154.52) | 3,574.1 (932.91) |
| AUC(0-t) (days · μg/ml) | 115.3 (99.05) | 330.3 (92.32) | 968.8 (139.82) | 3,268.8 (769.18) |
| Cmax (μg/ml) | 9.3 (3.60) | 29.7 (6.25) | 74.8 (10.37) | 256.1 (48.90) |
| t1/2 (days) | 22.2 (11.40) | 21.6 (7.06) | 20.4 (3.53) | 26.9 (10.71) |
| λz (1/days) | 0.037 (0.01) | 0.035 (0.01) | 0.035 (0.01) | 0.030 (0.01) |
| CL (ml/kg · day) | 2.44 (0.88) | 2.81 (0.70) | 2.93 (0.47) | 2.96 (0.71) |
| Vz (ml/kg) | 66.51 (16.59) | 84.24 (21.84) | 84.41 (7.93) | 114.13 (56.99) |
| MRT (days) | 29.80 (14.15) | 26.10 (7.14) | 25.19 (5.10) | 31.10 (9.14) |
| Tmax (h) | 7.35 (10.47) | 1.11 (2.05) | 0.92 (0.97) | 3.36 (6.59) |
a
AUC0-t, AUC from 0 to t h; λz, elimination constant; CL, clearance; Vz, apparent volume of distribution during terminal phase; MRT, mean residence time; Tmax, time to maximum concentration of drug in serum.