Pharmacodynamic outcomes
HYPERURICEMIA
The mean percentage changes in serum UA levels from baseline in the five cohorts are shown in Fig. Mean percentage change from baseline in serum UA at each time point. The error bar indicates the standard deviation. UA, uric acid.Following multiple daily doses of 30–120 mg HP501 for 10 days, serum UA levels continued to decline upon repeated dosing. On Day 13, the median TThe lowest serum UA level below 360 μmol/L was observed in 2 out of 10 patients (20.00%) in the 30 mg cohort, 5 out of 10 patients (50.00%) in the 50 mg cohort, 5 out of 10 patients (50.00%) in the 60 mg cohort, 10 out of 12 patients (83.33%) in the 90 mg cohort and 9 out of 12 patients (75.00%) in the 120 mg cohort (Table The number of patients achieving a serum UA level ≤ 360 μmol/L at each time point on Day 13 [n (%)].The above results indicate that the serum UA decline was saturated at the 90 mg dose level in patients with hyperuricemia. Owing to the pharmacodynamic outcomes of 30–120 mg cohorts, the UA-lowering effect of HP501 was not expected to increase when the administration dose was over 90 mg. Thus, the 150 mg and 180 mg cohorts were not included in this study.