Table 9.
Pharmacokinetic parameters.
| ISU303 1 mg/kg | |||||
|---|---|---|---|---|---|
| Cmax (mU/mL) | Tmax (h) | AUClast (h·mU/mL) | CL (mL/h/kg) | t1/2 (h) | |
| n | 10 | 10 | 10 | 8* | 8* |
| mean | 290.5 | 4.6 | 1048.6 | 77.5 | 1.13 |
| SD | 128.1 | 1.9 | 569.1 | 17.9 | 0.34 |
| min | 171.5 | 1.0 | 472.5 | 51.9 | 0.92 |
| median | 238.7 | 5.0 | 941.5 | 74.1 | 1.02 |
| max | 601.3 | 8.0 | 2530.5 | 104.1 | 1.96 |
AUClast = area under the curve from the time of dosing to the last measurable concentration, Cmax = maximal concentration of drug, CL = serum clearance, FD = Fabry disease, Tmax = time to reach Cmax, t1/2 = half-life.
*
PK parameters were not calculated in 2 patients with neutralizing anti-drug antibodies (patient No. 6 and 7).