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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Gout With Hyperuricemia in Adults
• Intervention / Treatment: Drug: HR091506 tablets + placebo of febuxostat tablets; Drug: febuxostat tablets + placebo of HR091506 tablets

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huize Han; Phone Number: +0518-82342973; Email: huize.han@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; HR091506 tablets + placebo of febuxostat tablets	Drug: 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
Active Comparator: Treatment group B; febuxostat tablets + placebo of HR091506 tablets	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.	on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)	Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.	on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at TOC	Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
The proportion of subjects with serum uric acid level < 360μmol/L on Day 29.	on Day 29.
The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.	on Day 29.
Change of serum uric acid level from baseline on Day 15	from baseline on Day 15
Change of serum uric acid level from baseline on Day 29	from baseline on Day 29

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2022
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout; Arthritis, Gouty; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: HR091506-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No