Table 4.
Pharmacokinetic parameters of BAN2401
| Cohort | n | Dose (mg/kg) | Cmax (μg/mL) | AUC(0-24) (μg*h/mL) | AUC(0-inf) (μg*h/mL) | t1/2 (h) |
|---|---|---|---|---|---|---|
| SAD1 | 6 | 0.1 | NC | NC | NC | NC |
| SAD2 | 6 | 0.3 | 8.50 (2.4) | NC | NC | NC |
| SAD3 | 6 | 1 | 24.7 (3.6) | NC | NC | NC |
| SAD4 | 6 | 3 | 74.2 (11) | 1390 (140) | 7430 (1210) | NC |
| SAD5 | 6 | 10 | 264 (32.4) | 5010 (550) | 38000 (7340) | 165 (45.5) |
| SAD6 | 6 | 15 | 418 (54.5) | 7630 (593) | 66900 (17600) | 174 (36.1) |
| MAD1 | 6 | 0.3 | 7.26 (1.5) | 133 (23) | NA | NC |
| MAD2 | 3 | 1 | 30.6 (4.6) | 470 (110) | NA | NC |
| MAD3 | 5 | 3 | 68.8 (9) | 1220 (132) | NA | NC |
| MAD4 | 6 | 10 | 307 (70.2) | 5720(1230) | NA | 127(30) |
PK parameters for the MAD cohorts were calculated after the final dose of BAN2401. Values reported are Mean (SD)
AUC area under the curve, NC not calculated due to insufficient data, NA not applicable for dosing with multiple doses.