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Predicted PK parameters for Fc FVIII in humans.
| Species | Dose (IU/kg) | rFVIII Observed | Fc FVIII Observed | Fc FVIII Predicted for Humans | |||
|---|---|---|---|---|---|---|---|
| Vss (mL) | CL (mL/h | Vss (mL) | CL (mL/h) | Vss (mL) | CL (mL/h) | ||
| Mice* | 125 | 1.13 | 0.155 | 1.53 | 0.088 | 5440 | 191 |
| HA Dogs | 117/125** | 1090 | 111 | 1470 | 86.7 | 5410 | 191 |
| HA Humans | 25 | 3830 | 223 | 4060 | 150 | -- | -- |
| HA Humans | 65 | 4520 | 284 | 4940 | 183 | -- | -- |
Average of normal and HA
FVIII dose 117 IU/kg for rFVIII, 125 IU/kg for Fc FVIII
