PK parameters of nemvaleukin in male cynomolgus monkeys after repeated intravenous (0.1 mg/kg for 5 consecutive days, on days 1–5) or subcutaneous (0.5 mg/kg on days 1 and 4) doses
Dose route | Dose | Day | Cmax | Tmax | Ctrough | AUCτa | AUCt | AUCtotal |
---|---|---|---|---|---|---|---|---|
mg/kg | ng/ml | h | ng/ml | ng·h/ml | ng·h/ml | ng·h/ml | ||
Intravenous | 0.1 | 1 | 2575 ± 176 | 0.083 (0.083, 0.083) | <LLOQ | 9035 ± 602 | 9035 ± 602 | 41,753 ± 2213b |
5 | 2096 ± 80 | 0.083 (0.083, 0.083) | 9.62 ± 1.39 | 5159 ± 301 | 5611 ± 429 | 30,124 ± 1112c | ||
Subcutaneous | 0.5 | 1 | 911 ± 432 | 8 (8, 8) | <LLOQ | 17,656 ± 6700 | 17,656 ± 6700 | 33,402 ± 9204 |
4 | 1006 ± 119 | 2 (2, 8) | 10.0 ± 1.25 | 15,214 ± 2529 | 15,746 ± 2601 |
N = 3 per treatment group, LLOQ = 1.00 ng/ml.
Mean (± S.D.) for all parameters except Tmax [median (min, max)].
↵aτ = 24 hours for intravenous dosing regimen and 72 hours for subcutaneous dosing regimen.
↵bCalculated based on AUC24h,day 1 × 4 + AUCt,day 5.
↵cCalculated based on AUC24h,day 1 + AUC24h,day 5 × 3 + AUCt,day 5.