Back to resultsA Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
Primary Purpose
Primary Gout With Hyperuricemia in Adults
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HR091506 tablets + placebo of febuxostat tablets
febuxostat tablets + placebo of HR091506 tablets
Sponsored by
About this trial
This is an interventional treatment trial for Primary Gout With Hyperuricemia in Adults
Eligibility Criteria
Inclusion Criteria:
- 18 - 65 years old, male or female.
- BMI: 18.0 - 30 kg/m2.
- Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.
- Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.
- Willing to use 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.
- Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.
- Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
- Major cardiovascular disease within 6 months before randomization.
- History of chronic infection or recurrent infection within 1 year 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group A
Treatment group B
Arm Description
HR091506 tablets + placebo of febuxostat tablets
febuxostat tablets + placebo of HR091506 tablets
Outcomes
Primary Outcome Measures
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)
Secondary Outcome Measures
The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at TOC
The proportion of subjects with serum uric acid level < 360μmol/L on Day 29.
The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.
Change of serum uric acid level from baseline on Day 15
Change of serum uric acid level from baseline on Day 29
Full Information
NCT ID
NCT05347498
First Posted
April 21, 2022
Last Updated
April 21, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05347498
Brief Title
A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
Official Title
Study on Efficacy and Safety of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2022 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Gout With Hyperuricemia in Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
HR091506 tablets compared with febuxostat tablets
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
HR091506 tablets + placebo of febuxostat tablets
Arm Title
Treatment group B
Arm Type
Active Comparator
Arm Description
febuxostat tablets + placebo of HR091506 tablets
Intervention Type
Drug
Intervention Name(s)
HR091506 tablets + placebo of febuxostat tablets
Intervention Description
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
Intervention Name(s)
febuxostat tablets + placebo of HR091506 tablets
Intervention Description
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
Primary Outcome Measure Information:
Title
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
Time Frame
on Day 15.
Title
Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)
Time Frame
Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
Secondary Outcome Measure Information:
Title
The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.
Time Frame
on Day 15.
Title
Proportion of subjects with serum uric acid level < 360μmol/L at TOC
Time Frame
Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
Title
The proportion of subjects with serum uric acid level < 360μmol/L on Day 29.
Time Frame
on Day 29.
Title
The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.
Time Frame
on Day 29.
Title
Change of serum uric acid level from baseline on Day 15
Time Frame
from baseline on Day 15
Title
Change of serum uric acid level from baseline on Day 29
Time Frame
from baseline on Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 - 65 years old, male or female.
BMI: 18.0 - 30 kg/m2.
Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.
Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.
Willing to use 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.
Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.
Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
Major cardiovascular disease within 6 months before randomization.
History of chronic infection or recurrent infection within 1 year 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huize Han
Phone
+0518-82342973
Email
huize.han@hengrui.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
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