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A 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
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Gout With Hyperuricemia in Adults

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    April 21, 2022
    Last Updated
    April 21, 2022
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    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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