TABLE 3

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 routeDoseDayCmaxTmaxCtroughAUCτaAUCtAUCtotal
mg/kgng/mlhng/mlng·h/mlng·h/mlng·h/ml
Intravenous0.112575 ± 1760.083 (0.083, 0.083)<LLOQ9035 ± 6029035 ± 60241,753 ± 2213b
52096 ± 800.083 (0.083, 0.083)9.62 ± 1.395159 ± 3015611 ± 42930,124 ± 1112c
Subcutaneous0.51911 ± 4328 (8, 8)<LLOQ17,656 ± 670017,656 ± 670033,402 ± 9204
41006 ± 1192 (2, 8)10.0 ± 1.2515,214 ± 252915,746 ± 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.