Figure 5.
Serum concentration time profile of SRK-181 following multiple doses. (A) Male and female SD rats were administered an intravenous (IV) bolus dose of SRK-181 at 30, 100, or 200 mg/kg on days 1, 8, 15, 22, and 29. Cmax, area under the concentration time curve (AUC)0-168, and AUC0-696 (on day 29) increased approximately dose proportionally from 30 to 300 mg/kg and there were minimal-to-no differences between sexes. There were no confirmed Antidrug antibody (ADA) positive samples in the 100 or 200 mg/kg SRK-181 treatment groups nor any decrease in exposure consistent with an immune response. (B) Male and female cynomolgus monkeys were administered an IV bolus dose of SRK-181 at 30, 100, or 300 mg/kg on days 1, 8, 15, 22, and 29. Cmax and AUC0-168 increased approximately dose proportionally from 30 to 300 mg/kg, and there were minimal-to-no differences between sexes. There were no confirmed ADA positive samples in any SRK-181 treatment group nor any decrease in exposure consistent with an immune response. Data shown are mean ± standard deviation. Dose symbols: 30 (diamonds), 100 (triangles), 200 (squares), and 300 (circles) mg/kg.