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

NCT ID: NCT05347498

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-07-31

Brief 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.

Conditions

Primary Gout With Hyperuricemia in Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A

HR091506 tablets + placebo of febuxostat tablets

Group Type: EXPERIMENTAL

HR091506 tablets + placebo of febuxostat tablets

Intervention Type: DRUG

HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd in Week 1 and 2, HR091506 tablets 80mg qd + placebo of febuxostat tablets 80mg qd in Week 3 and 4

Treatment group B

febuxostat tablets + placebo of HR091506 tablets

Group Type: ACTIVE_COMPARATOR

febuxostat tablets + placebo of HR091506 tablets

Intervention Type: DRUG

febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd in Week 1 and 2, febuxostat tablets 80mg qd + placebo of HR091506 tablets 80mg qd in Week 3 and 4

Interventions

HR091506 tablets + placebo of febuxostat tablets

HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd in Week 1 and 2, HR091506 tablets 80mg qd + placebo of febuxostat tablets 80mg qd in Week 3 and 4

Intervention Type: DRUG

febuxostat tablets + placebo of HR091506 tablets

febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd in Week 1 and 2, febuxostat tablets 80mg qd + placebo of HR091506 tablets 80mg qd in Week 3 and 4

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Huize Han

Role: CONTACT

huize.han@hengrui.com

+0518-82342973

Other Identifiers

HR091506-103

Identifier Type: -

Identifier Source: org_study_id