TABLE 3.
Summary of PK parameters of etesevimab after a single-dose intravenous infusiona
| Dose (mg/kg) | Cmax (mean μg/ml ± SD; CV%) | Tmax median h (min, max) | AUC0–last (mean μg·h/ml ± SD; CV%) | Tlast median h (min, max) | AUC0–∞ (mean μg·h/ml ± SD; CV%) | CL (mean ml/h ± SD; CV%) | Vz (mean ml ± SD; CV%) | t1/2 (mean h ± SD; CV%) | MRT0–last (mean h ± SD; CV%) | MRT0–∞ (mean h ± SD; CV%) |
|---|---|---|---|---|---|---|---|---|---|---|
| 2.5 (n = 3) | 51.8 ± 5.52; −11% | 3 (2.00,5.00) | 26,700 ± 2,850; −11% | 2,041.82 (2,039.90, 2,041.92) | 30,800 ± 3,070; −10% | 5.40 ± 0.493; −9% | 5,580 ± 649; −12% | 716 ± 29.8; −4% | 678 ± 13.7; −2% | 996 ± 33.6; −3% |
| 10 (n = 9) | 202 ± 19.4; −10% | 2 (1.00,5.00) | 102,000 ± 11,500; −11% | 2,015.07 (2,014.57, 2,017.23) | 119,000 ± 15,800; −13% | 5.63 ± 0.746; −13% | 5,700 ± 645; −11% | 708 ± 80.2; −11% | 657 ± 43.1; −7% | 989 ± 126; −13% |
| 25 (n = 9) | 526 ± 55.7; −11% | 1.03 (1.00,9.00) | 261,000 ± 13,000; −5% | 2,015.12 (2,014.98, 2,016.42) | 296,000 ± 12200; −4% | 5.39 ± 0.750; −14% | 4,940 ± 793; −16% | 643 ± 109; −17% | 653 ± 31.5; −5% | 925 ± 118; −13% |
| 50 (n = 9) | 1,020 ± 66.3; −6% | 2 (1.02,3.00) | 512,000 ± 40,300; −8% | 2,015.13 (2,014.73, 2,018.00) | 566,000 ± 57,000 (10%)b | 5.61 ± 0.674 (12%)b | 5,520 ± 1010 (18%)b | 684 ± 114 (17%)b | 672 ± 41.9; −6% | 947 ± 117; (12%)b |
n, number of subjects; Cmax, maximum concentration; Tmax, time to reach maximum concentration; AUC0–last, area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration; Tlast, time of the last quantifiable concentration; AUC0–∞, area under the curve from time zero to infinity; CL, clearance; Vz, volume of distribution; t1/2, elimination half-life; MRT0–last, mean residence time from time zero to the time of the last quantifiable concentration; MRT0–∞, mean residence time from time zero to infinity. Note that pharmacokinetic parameters are presented as mean ± standard deviation (SD) (CV%). T max and Tlast are presented as median (minimum, maximum).
λz of 4 subjects in the 50 mg/kg group could not be calculated accurately; the number of subjects included in the analysis for AUC0–∞, CL, Vz, t1/2, and MRT0–∞ was 5.