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. 2022 Nov 15;26:355. doi: 10.1186/s13054-022-04204-9

Table 3.

MEDI3902 PK parameters

PK parameter MEDI3902 500 mg (N = 16) MEDI3902 1500 mg (N = 85)
n Mean (SD) n Mean (SD)
Serum
Cmax, µg/mL 16 87.6 (23.9) 84 299 (94.1)
C21, µg/mL 14 2.56 (2.23) 72 9.46 (7.91)
AUC0–21, day*µg/mL 16 418 (126) 81 1410 (599)
AUC∞, day*µg/mL 16 440 (135) 81 1510 (675)
CL, L/day 16 1.31 (0.64) 81 1.27 (0.86)
t½, day 16 6.56 (4.03) 81 5.65 (2.69)
n/N % n/N %
Subjects with serum MEDI3902 levels > target level of 1.7 µg/mL on day 21 7/14 50.0% 58/72 80.6%
Endotracheal aspirate
Cmax, µg/mL n/a 0.083
AUC0–21, day*µg/mL n/a 0.704
AUC∞, day*µg/mL n/a 0.784
t½, day n/a 6.3

AUC0–21 = the area under the concentration–time curve from time zero to 21 days post-dose. AUC = the area under the concentration–time curve from zero to infinity. CL = clearance. Cmax = maximum observed concentration. C21 = concentration 21 days post-dose. IV = intravenous. n/a = not applicable. SD = standard deviation. t½ = half-life

Due to the large variability in measured endotracheal aspirate concentrations and limited samples per subject, it was not plausible to calculate endotracheal aspirate PK parameter at an individual level. Therefore, endotracheal aspirate PK parameters were calculated based on geometric mean concentration–time profile