Summary PK parameters of ISB 1342 in cynomolgus monkeys: consecutive-dose study
Dose level (μg/kg) . | C0 (ng/mL) . | Cmax (ng/mL) . | Tmax (h) . | AUC0-t (h × ng/mL) . | tlast (h) . | AUC0-∞ (h × ng/mL) . | t1/2 (h) . | ADA detected . |
---|---|---|---|---|---|---|---|---|
1 | NE | 0.44 | 4.0 | 8.8 | 36 | NE | NE | None |
100 | 206 | 131 | 4.0 | 4589 | 252 | 4863 | 58.2∗ | Day 43 |
1000 | 462 | 165.95 | 4.0 | 2193 | 16 | 4355∗ | 2.8 | Day 43 |
Dose level (μg/kg) . | C0 (ng/mL) . | Cmax (ng/mL) . | Tmax (h) . | AUC0-t (h × ng/mL) . | tlast (h) . | AUC0-∞ (h × ng/mL) . | t1/2 (h) . | ADA detected . |
---|---|---|---|---|---|---|---|---|
1 | NE | 0.44 | 4.0 | 8.8 | 36 | NE | NE | None |
100 | 206 | 131 | 4.0 | 4589 | 252 | 4863 | 58.2∗ | Day 43 |
1000 | 462 | 165.95 | 4.0 | 2193 | 16 | 4355∗ | 2.8 | Day 43 |
AUC0-∞, area under the (serum) concentration-time curve extrapolated out to infinity; AUC0-t, area under the plasma concentration-time curve from time zero to time t; C0, initial concentration; NE, not estimable; t½, terminal elimination half-life; tlast, time of the last measurable (positive) concentration; Tmax, time to reach maximum serum concentration after drug administration.
N = 1.