NCT05347498Unknown1 期
Study on Efficacy and Safety of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 主要终点
- The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years old, male or female.
- •BMI: 18.0 - 30 kg/m
- •Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.
- •Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.
- •Willing to use contraceptive measures during the study.
- •Able and willing to provide a written informed consent.
排除标准
- •History of acute gout attack within 4 weeks before randomization.
- •Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.
- •Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
- •Major cardiovascular disease within 6 months before randomization.
- •History of chronic infection or recurrent infection within 1 year before randomization.
- •History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
- •History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
- •Subjects with poorly controlled blood pressure or diabetes mellitus.
- •History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
- •History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
- •Abnormal laboratory tests that may affect subjects participating in the research.
- •Combined use of prohibited drugs.
- •Allergic to ingredient or component of the experimental drug.
- •Participated in other clinical trials within 1 month before randomization.
- •Pregnant or nursing women.
- •History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
- •The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Treatment group A
Experimental
HR091506 tablets + placebo of febuxostat tablets
干预措施: HR091506 tablets + placebo of febuxostat tablets (Drug)
Treatment group B
Active Comparator
febuxostat tablets + placebo of HR091506 tablets
干预措施: febuxostat tablets + placebo of HR091506 tablets (Drug)
结局指标
主要结局
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
时间窗: on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)
时间窗: Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
次要结局
- The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.(on Day 15.)
- Proportion of subjects with serum uric acid level < 360μmol/L at TOC(Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29)
- The proportion of subjects with serum uric acid level < 360μmol/L on Day 29.(on Day 29.)
- The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.(on Day 29.)
- Change of serum uric acid level from baseline on Day 15(from baseline on Day 15)
- Change of serum uric acid level from baseline on Day 29(from baseline on Day 29)
研究者
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