TABLE 2.
Mean pharmacokinetic parameters by dose
| Parameter | Mean result ± SD for tefibazumab dose (mg/kg):
|
|||
|---|---|---|---|---|
| 2 (n = 6) | 5 (n = 4) | 10 (n = 4) | 20 (n = 4) | |
| Cmax (μg/ml) | 59 ± 7 | 127 ± 10 | 252 ± 33 | 492 ± 79 |
| Tmax (h)a | 1.0 (0.8-48.8) | 1.0 (1.0-6.0) | 1.0 (1.0-1.0) | 1.0 (1.0-6.0) |
| AUC(0-inf) (h · mg/ml) | 25.5 ± 8.3 | 47.2 ± 2.7 | 82.5 ± 10.8 | 15.8 ± 13.5 |
| Elimination t1/2 (days) | 23.5 ± 4.6 | 21.0 ± 3.7 | 20.7 ± 3.9 | 21.3 ± 2.8 |
| CL (ml/h) | 6.0 ± 1.9 | 9.2 ± 0.8 | 10.2 ± 1.4 | 9.9 ± 1.8 |
| V (liter) | 4.7 ± 1.2 | 6.7 ± 1.3 | 7.2 ± 1.0 | 7.2 ± 1.2 |
a
Median (minimum-maximum).