Clinical trial
Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Name
HR091506-302
Description
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.
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-11-01
Trial end
2025-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
HR091506 tablets + placebo of febuxostat tablets
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.
Arms:
Treatment group A: HR091506 tablets + placebo of febuxostat tablets
febuxostat tablets + placebo of HR091506 tablets
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.
Arms:
Treatment group B: febuxostat tablets + placebo of HR091506 tablets
Size
750
Primary endpoint
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
Week 28
Eligibility criteria
Inclusion Criteria:
1. 18-75 years old, male or female;
2. BMI: 18.0-30.0 kg/m2;
3. Meet the 2015 ACR/EULAR gout classification criteria;
4. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
5. Willing to ues contraceptive measures during the study;
6. Able and willing to provide a written informed consent.
Exclusion Criteria:
1. History of acute gout attack within 4 weeks before randomization.
2. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
3. Subjects with major cardiovascular disease within 6 months before randomization.
4. History of chronic infection or recurrent infection within 1year before randomization.
5. History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
6. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
7. Subjects with poorly controlled blood pressure or diabetes mellitus.
8. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
9. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
10. Abnormal laboratory tests that may affect subjects participating in the research.
11. Combined use of prohibited drugs.
12. Allergic to ingredient or component of the experimental drug.
13. Participated in other clinical trials within 1 month before randomization.
14. Pregnant or nursing women.
15. History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 750, 'type': 'ESTIMATED'}}
Updated at
2023-11-18
1 organization
2 products
1 indication
Product
HR091506Indication
Gout with Hyperuricemia in AdultsOrganization
Jiangsu HengRui MedicineProduct
Febuxostat