A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults

• Status: Not yet recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Febuxostat

Criteria

Inclusion Criteria:

1. 18 - 65 years old, male or female.

2. BMI: 18.0 - 30 kg/m2.

3. Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.

4. Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.

5. Willing to use 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. Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.

3. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.

4. Major cardiovascular disease within 6 months before randomization.

5. History of chronic infection or recurrent infection within 1 year before randomization.

6. History of malignant tumor or current history of combined malignant tumor within 5 years before screening.

7. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.

8. Subjects with poorly controlled blood pressure or diabetes mellitus.

9. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.

10. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.

11. Abnormal laboratory tests that may affect subjects participating in the research.

12. Combined use of prohibited drugs.

13. Allergic to ingredient or component of the experimental drug.

14. Participated in other clinical trials within 1 month before randomization.

15. Pregnant or nursing women.

16. History of drug abuse, drug use and/or excessive drinking within 1 year before screening.

17. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.