Table 1.

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
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
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.

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