Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

Official Title
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Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

Conditions
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Gout With Hyperuricemia in Adults

Intervention / Treatment
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* Drug: HR091506 tablets + placebo of febuxostat tablets
* Drug: febuxostat tablets + placebo of HR091506 tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old, male or female; BMI: 18.0-30.0 kg/m2; Meet the 2015 ACR/EULAR gout classification criteria; Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid; Willing to ues contraceptive measures during the study; Able and willing to provide a written informed consent. Exclusion Criteria: History of acute gout attack within 4 weeks before randomization. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization. Subjects with major cardiovascular disease within 6 months before randomization. History of chronic infection or recurrent infection within 1year 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: HR091506 tablets + placebo of febuxostat tablets<br> | Drug: HR091506 tablets + placebo of febuxostat tablets<br>* HR091506 tablets 20mg qd + placebo of febuxostat tablets 20mg qd from Week 1 to 4, HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd from Week 5 to 28.<br>|
| Active Comparator: Treatment group B: febuxostat tablets + placebo of HR091506 tablets<br> | Drug: febuxostat tablets + placebo of HR091506 tablets<br>* febuxostat tablets 20mg qd + placebo of HR091506 tablets 20mg qd from Week 1 to 4, febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd from Week 5 to 28.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28 |  | Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with serum uric acid level < 360 μmol/L at each visit. |  | at week 4,8,12,16,20and24 after administration | 
| Proportion of subjects with serum uric acid level < 300 μmol/L at each visit |  | at week 4,8,12,16,20and24 after administration | 
| Change of serum uric acid level from baseline to every visit |  | at week 4,8,12,16,20and24 after administration | 
| Proportion of subjects with ≥1 gout flare during treatment stage |  | during treatment stage |