NCT04180982Unknown2 期
A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 84
- 主要终点
- Adverse Events(AEs) and Serious Adverse Events(SAEs)
研究概览
简要总结
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.
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
- Double (Participant, Investigator)
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
- •Subject has a body mass index ≥18 and ≤30 kg/m2;
- •Screening sUA value ≥8mg/dl;
- •Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
排除标准
- •Subject known or suspected of being sensitive to the study drugs or its ingredient；
- •ALT、AST、TBIL>1.5ULN;
- •History of kidney stones or screening kidney stones by B-ultrasound；
- •History of malignancy；
- •History of xanthinuria；
- •Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.
研究组 & 干预措施
Treatment group A
Experimental
SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd.
干预措施: SHR4640 dose1 plus Febuxostat dose1 (Drug)
Treatment group B
Experimental
SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd.
干预措施: SHR4640 dose1 plus Febuxostat dose2 (Drug)
Treatment group C
Experimental
SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd.
干预措施: SHR4640 dose2 plus Febuxostat dose3 (Drug)
结局指标
主要结局
Adverse Events(AEs) and Serious Adverse Events(SAEs)
时间窗: Up to week 4
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability)
次要结局
- Percentage of subjects with a serum uric level≤360μmol/L(At week1, 2, 3 and 4)
- Percentage change from baseline in serum uric level .(At week1, 2, 3 and 4)
- Actual change from baseline in serum uric level(At week1, 2, 3 and 4)
研究者
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