Table 1.
Comparison of mean exposure (AUC0-last) in mouse, dog and human based following intravenous administration of pixatimod
| Species | Dose (mg/kg) | HEDa / human dose (mg) | AUC0-last (μg.h/mL) b Week 1 | AUC0-last (μg.h/mL) b Week 4 |
|---|---|---|---|---|
| Mouse | 15 | 73 | 1358 c | N.D. |
| Dog | 2.5 | 83 | 697 | 1372 |
| 7.5 | 250 | 1809 | 4936 | |
| 20 | 666 | 6883 | 10,536 | |
| Human | – | 25 | 465 | 610 |
| – | 50 | 709 | 1688 | |
| – | 100 | 1209 | 2381 | |
| – | 150 | 1441 | 2781 |
aHED – Human equivalent dose conversion (https://www.fda.gov/downloads/drugs/guidances/ucm078932.pdf)
bArea under the pixatimod concentration-time curve from time 0 h (relative to applicable dose) to the last measureable concentration over the dosing interval; derived from the measured concentration values using linear trapezoidal summation
cOriginally published in [29]
N.D. Not Determined