Primary Gout With Hyperuricemia in AdultsPhase 1NCT05347498
A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
A Phase 1 study of Primary Gout With Hyperuricemia in Adults, run by Jiangsu HengRui Medicine Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Gout With Hyperuricemia in Adults
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 31 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- HR091506 tablets + placebo of febuxostat tablets, febuxostat tablets + placebo of HR091506 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR091506 tablets + placebo of febuxostat tabletsDrug
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
febuxostat tablets + placebo of HR091506 tabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | HR091506 tablets + placebo of febuxostat tablets Receives: Drug: HR091506 tablets + placebo of febuxostat tablets |
| Treatment group B | Active comparator | febuxostat tablets + placebo of HR091506 tablets Receives: Drug: febuxostat tablets + placebo of HR091506 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
Measured: on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)
Measured: Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
Secondary outcomes (6)
The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.
Measured: on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at TOC
Measured: 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.
Measured: on Day 29.
The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.
Measured: on Day 29.
Change of serum uric acid level from baseline on Day 15
Measured: from baseline on Day 15
Change of serum uric acid level from baseline on Day 29
Measured: from baseline on Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Gout With Hyperuricemia in AdultsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR091506 tablets compared with febuxostat tablets
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347498
- Sponsor's protocol ID
- HR091506-103
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
- ClinicalTrials.gov ID
- NCT05347498
- Acronym / sponsor ID
- HR091506-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HR091506 tablets compared with febuxostat tablets
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HR091506 tablets + placebo of febuxostat tabletsHR091506 tablets + placebo of febuxostat tablets |
| Treatment group B | Active comparator | Drug: febuxostat tablets + placebo of HR091506 tabletsfebuxostat tablets + placebo of HR091506 tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR091506 tablets + placebo of febuxostat tabletsHR091506 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 | Drug | Treatment group A |
| febuxostat tablets + placebo of HR091506 tabletsfebuxostat 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 | Drug | Treatment group B |
Primary outcome
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
Time frame: on Day 15.
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
6 secondary outcomes
The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.
Time frame: on Day 15.
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
The proportion of subjects with serum uric acid level < 360μmol/L on Day 29.
Time frame: on Day 29.
The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.
Time frame: on Day 29.
Change of serum uric acid level from baseline on Day 15
Time frame: from baseline on Day 15
Change of serum uric acid level from baseline on Day 29
Time frame: from baseline on Day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Primary Gout With Hyperuricemia in Adults, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huize Han (+0518-82342973, huize.han@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15. (time frame: on Day 15.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.