STP0404 was administered orally to 10 or 15 SD rats/sex/group at dose levels of 100, 300 and 600 mg/kg/day for 4 weeks to evaluate its potential toxicity. The reversibility of any effects was also assessed following a 2-week untreated recovery period. Control animals (15 animals/sex) received the vehicle, 0.5 w/v% methylcellulose solution, in a similar manner for comparison. In addition, plasma STP0404 concentrations were determined using TK satellite animals (3 animals/sex/group) to evaluate systemic exposure of the animals to the test article. (Study no. YL18402). STP0404 was administered orally as a capsule to 4 or 6 dogs/sex/group at dose levels of 30, 60 and 90 mg/kg/day for 4 weeks to evaluate its potential toxicity. Control animals (6 animals/sex) received empty gelatin capsules in a similar manner for comparison. The reversibility of any effects was also assessed following a 2-week untreated recovery period (2 animals/sex/group for the control and 90 mg/kg/day groups). In addition, plasma STP0404 concentrations were determined using all tested animals (including control group) to evaluate systemic exposure of the animals to the test article (Study no. YL18403). The test was performed according to the Standard Operating Procedures (SOP) the Good Laboratory Practice (GLP) system of the INA Research.

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