This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia.
This study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol/L or greater than or equal to 480 μmol/L. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.
Voluntary participation in this trial and signing of the informed consent form, and those who can complete the trial according to the protocol;
Age between 18 and 75 years old (inclusive of the boundary value, based on the date of signing the informed consent form), regardless of gender;
Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2;
Meeting the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria, and serum uric acid (sUA) ≥ 420 μmol/L during the screening period;
Those who are known or suspected to be allergic to the test drug or its components, or who have previously been intolerant to febuxostat or have contraindications.
Subjects with secondary gout accompanied by hyperuricemia caused by other diseases or medications.
Those who have had acute gout attacks within the previous 2 weeks.
Those who have been diagnosed with uric acid nephropathy in the past or have imaging or clinical manifestations of urinary system stones (such as hematuria, back pain) within the previous 2 weeks.