Can a new injection tame Gout's uric acid?
NCT ID NCT07752810
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This study tests an investigational drug called HZBio1 in people with gout. The goal is to see if it is safe and how well it lowers uric acid levels. Participants receive multiple injections of HZBio1 over several weeks. The trial includes adults aged 18 to 70 with gout and elevated uric acid.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HZBio1, an investigational drug given by injection
- What this could lead to
- If successful, HZBio1 could offer a new treatment option to help control uric acid levels and reduce gout flares.
- What could go wrong
- This is an early-stage trial, so the drug may not work as hoped or may cause side effects. More research will be needed before it could become available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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90 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Fully informed and signed the Informed Consent Form (ICF); * Diagnosed with gout per the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, with a screening serum uric acid (sUA) level ≥7.0 mg/dL, and in a non-acute phase at the time of first dose; * Aged 18-70 years (inclusive), male or female; * Body mass index (BMI) ≥18.5 kg/m²; * Failure to achieve sUA \<7.0 mg/dL after ≥8 weeks of standardized treatment with conventional urate-lowering therapy (ULT) (effective doses include but are not limited to: allopurinol ≥300 mg/day, febuxostat ≥40 mg/day, or benzbromarone ≥50 mg/day; investigators may adjust doses based on tolerance and renal/hepatic function) OR contraindication/intolerance to ULT; No use of oral urate-lowering drugs within 1 week prior to randomization; * Negative serum pregnancy test for women of childbearing potential; * Agreement by subjects and their partners of childbearing potential to use highly effective contraception or practice abstinence during the study and for 6 months after the last dose; * Ability to understand and comply with protocol requirements; investigators anticipate completion of the entire study. Exclusion Criteria: * Intolerance to multiple intramuscular injections. * Known hypersensitivity to the investigational drug, PEG-containing drugs, NSAIDs (e.g., ibuprofen, acetaminophen), or therapeutic protein products (e.g., fresh/frozen plasma, human serum albumin, cytokines, interleukins). * History of severe allergic reactions or hypersensitivity to foods, inhalants, contact substances, or drugs, or being allergy-prone (multiple drug/food allergies). * Acute gout flare within 2 weeks prior to baseline. * History of organ transplantation requiring immunosuppressive therapy. * Use of prednisone \>10 mg/day (or equivalent) within 1 week prior to screening. * Contraindications to antihistamine use. * History of severe diseases (digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematologic, or immune systems) within 3 months prior to screening. * New or worsening coronary artery disease or congestive heart failure within 3 months prior to screening, or history of: 1. Acute coronary syndrome (e.g., acute myocardial infarction \[AMI\], unstable angina). 2. Coronary interventions (e.g., CABG, PTCA). 3. Stroke or transient ischemic attack. * Uncontrolled hypertension (resting systolic blood pressure \[SBP\] ≥180 mmHg and/or diastolic blood pressure \[DBP\] ≥110 mmHg). Exception: Subjects with controlled blood pressure after adjustment of antihypertensives per guidelines may be enrolled if rechecked during screening. * Severe peripheral vascular disease (e.g., disabling claudication, unhealed ischemic ulcers, or conditions requiring surgery/angioplasty). * Poorly controlled diabetes (HbA1c \>9.0%). * Vaccination within 1 month prior to baseline or plans to receive non-inactivated vaccines during the study. Note: Inactivated vaccines require a 2-week interval from study drug administration. * Active malignancy or history of malignancy within 5 years prior to screening (exceptions: basal/squamous cell skin cancer, excised cervical intraepithelial neoplasia, or carcinoma in situ). * History of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD level below the lower limit of normal. Testing sources: Results from the study site, tertiary hospitals, or Guangzhou Kingmed Center for Clinical Laboratory Co., Ltd. are acceptable. Sample disposal: Processed by Guangdong Environmental Living Waste Disposal Center Co., Ltd. * Laboratory abnormalities: A. Hemoglobin \<10 g/dL. B. Active hepatitis B (HBsAg+ with HBV DNA ≥500 IU/mL or 2500 copies/mL), HCV antibody+, HIV antibody+, or syphilis antibody+ (RPR/TPPA+). C. White blood cells \<3.0×10⁹/L. D. Platelets \<75×10⁹/L. E. ALT/AST \>3× upper limit of normal (ULN). * Participation in conflicting clinical trials (device or PEG/uricase-based drugs) within 12 weeks prior to screening. * Participation in other drug-intervention trials within 4 weeks prior to screening (or within 5 half-lives of the drug). * Blood donation/loss ≥400 mL or transfusion within 3 months prior to screening (excluding physiological blood loss in females). * Excessive alcohol consumption (\>14 units/week) within 4 weeks prior to screening (1 unit = 285 mL beer \[3.5%\], 25 mL spirits \[40%\], or 100 mL wine \[10%\]). * History of alcohol/drug abuse within 1 year prior to screening. * Pregnancy, lactation, or plans for pregnancy during the study. * Poor compliance (investigator's judgment). * Major surgery within 8 weeks prior to baseline or planned surgery during the study posing unacceptable risks. * Any other condition deemed by the investigator to compromise safety, validity, or suitability for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
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Other studies related to the condition(s) this trial covers.
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