Table 3.
Summary of rat and cynomolgus monkey PK parameters
| Species | Treatment | Dose (mg/kg) | PK Parameter |
||
|---|---|---|---|---|---|
| Cmax (µg/mL) | AUC0-inf (µg×day/mL) | CL (mL/day/kg) | |||
| Rat | Bemarituzumab | 1.5 (n = 3)a | 25.6 ± 1.30a | 35.8 ± 2.96a | 42.2 ± 3.67a |
| 10 (n = 3)a | 141 ± 50.2a | 484 ± 61.8a | 20.9 ± 2.51a | ||
| 30 (n = 3) | 699 ± 58.7 | 2620 ± 275 | 11.5 ± 1.27 | ||
| Cynomolgus monkey | Bemarituzumab | 10 (n = 1) | 257 | 1380 | 7.20 |
| 13.5 (n = 1) | 466 | 1510 | 8.88 | ||
| FPA144-F (the fucosylated version) | 10 (n = 1) | 297 | 1470 | 6.72 | |
| 10 (n = 1) | 313 | 1570 | 6.48 | ||
AUC0-inf = area under concentration-time curve from time 0 extrapolated to infinity; CL = clearance; Cmax = maximum observed plasma concentration.
Bemarituzumab or FPA144-F was administered as a single IV injection at the indicated doses. Plasma samples were collected at various time points following the dose, and concentrations were determined via ELISA. The PK parameters for rats are displayed as mean ±standard deviation (n = 3 per dose).
aTwo rats (1 of 4 in both the 1.5 and 10 mg/kg groups) were suspected of inadvertent subcutaneous dosing and therefore removed from the PK analysis.