TABLE 5.
Ibalizumab pharmacokinetic-parameter estimates for dose arms A and Ca
| Arm | Dose (mg/kg) | Cmax (μg/ml) | AUCall (μg·day/ml) | t1/2 (days) | VDss (ml/kg) | CLss (ml/day/kg) |
|---|---|---|---|---|---|---|
| A | 10 | 402 ± 117 (206-627) | 3,604 ± 1,530 (1,523-5,910) | 3.3 ± 0.9 (2.3-5.0) | 44 ± 21 (18-78) | 5.7 ± 2.3 (3.6-11) |
| C | 25 | 564 ± 267 (378-870) | 4,941 ± 4,433 (2,250-10,058) | 3.1 ± 1.8 (1.8-5.1) | 50 ± 20 (27-64) | 8.8 ± 4.7 (3.5-12) |
a
Mean ± standard deviation (minimum-maximum) from noncompartmental analysis (see Materials and Methods). The parameters are as follows: Cmax, maximum concentration of drug in serum; AUC, area under the concentration-time curve; t1/2, half-life; VDss, volume of distribution at steady state; CLss, clearance at steady state.