GoutPhase 1/2NCT07752810
Study of Safety, PK, and Efficacy of Multiple Ascending Doses of HZBio1 in Patients With Gout
A Phase 1/2 study testing Phase 1b: HZBio1 3mg, Phase 1b: HZBio1 6mg and Phase 1b: HZBio1 12mg in people with Gout, run by Hangzhou Grand Biologic Pharmaceutical, Inc. at 1 site in China.
Trial summary
Study YDHY (HZBio1)-001 (Ib/Ⅱ) is an open-label, dose-escalation and expansion, multicenter Phase Ib/II clinical trial conducted in China. The primary objectives were to evaluate the safety, tolerability, and PK of multiple-dose administration of HZBio1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gout
- What is being tested?
- Phase 1b: HZBio1 3mg, Phase 1b: HZBio1 6mg and Phase 1b: HZBio1 12mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2022to 19 May 2025
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- Acute coronary syndrome (e.g., acute myocardial infarction [AMI], unstable angina).
- Coronary interventions (e.g., CABG, PTCA).
- 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:
- 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+).
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Multicenter, Open-Label, Dose-Escalation and Expansion Phase Ib/II Study to Evaluate the Safety, PK, and PD of Multiple Ascending Doses of HZBio1 in Patients With Gout
Study YDHY (HZBio1)-001 (Ib/Ⅱ) is an open-label, dose-escalation and expansion, multicenter Phase Ib/II clinical trial conducted in China. The primary objectives were to evaluate the safety, tolerability, and PK of multiple-dose administration of HZBio1. The secondary objectives were to preliminarily explore the PD and immunogenicity of multiple-dose administration of HZBio1.
- Conditions
- Gout
- Being tested
- Phase 1b: HZBio1 3mg, Phase 1b: HZBio1 6mg, Phase 1b: HZBio1 12mg, Phase 2: HZBio1 6mg, Phase 2: HZBio1 9mg
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1b: HZBio1 3mgDrug
Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses
Phase 1b: HZBio1 6mgDrug
Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses
Phase 1b: HZBio1 12mgDrug
Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses
Phase 2: HZBio1 6mgDrug
Participants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations.
Phase 2: HZBio1 9mgDrug
Participants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations.
Phase 2: HZBio1 12mgDrug
Participants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: HZBio1 3 mg | Experimental | Participants receive HZBio1 at doses of 3 mg every two weeks for a total of six doses Receives: Drug: Phase 1b: HZBio1 3mg |
| Phase 1b: HZBio1 6 mg | Experimental | Participants receive HZBio1 at doses of 6 mg every two weeks for a total of six doses Receives: Drug: Phase 1b: HZBio1 6mg |
| Phase 1b: HZBio1 12 mg | Experimental | Participants receive HZBio1 at doses of 12 mg every two weeks for a total of six doses Receives: Drug: Phase 1b: HZBio1 12mg |
| Phase 2: HZBio1 6 mg | Experimental | Participants receive intramuscular injections of HZBio1 at 6 mg every two weeks. Participants receive a total of 14 administrations. Receives: Drug: Phase 2: HZBio1 6mg |
| Phase 2: HZBio1 9 mg | Experimental | Participants receive intramuscular injections of HZBio1 at 9 mg every two weeks. Participants receive a total of 14 administrations. Receives: Drug: Phase 2: HZBio1 9mg |
| Phase 2: HZBio1 12 mg | Experimental | Participants receive intramuscular injections of HZBio1 at 12 mg every two weeks. Participants receive a total of 14 administrations. Receives: Drug: Phase 2: HZBio1 12mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start23 Jun 2022
- Primary completion6 Dec 2024
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752810
- Sponsor's protocol ID
- YDHY (HZBio1)-001 (Ib/Ⅱ)
- Status last verified
- May 2025
- First submitted
- 2 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Dose-Escalation and Expansion Phase Ib/II Study to Evaluate the Safety, PK, and PD of Multiple Ascending Doses of HZBio1 in Patients With Gout
- ClinicalTrials.gov ID
- NCT07752810
- Acronym / sponsor ID
- YDHY (HZBio1)-001 (Ib/Ⅱ)
- Conditions
- Gout
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 7 Aug 2026 (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.
Study YDHY (HZBio1)-001 (Ib/Ⅱ) is an open-label, dose-escalation and expansion, multicenter Phase Ib/II clinical trial conducted in China. The primary objectives were to evaluate the safety, tolerability, and PK of multiple-dose administration of HZBio1. The secondary objectives were to preliminarily explore the PD and immunogenicity of multiple-dose administration of HZBio1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: HZBio1 3 mg | Experimental | Drug: Phase 1b: HZBio1 3mgParticipants receive HZBio1 at doses of 3 mg every two weeks for a total of six doses |
| Phase 1b: HZBio1 6 mg | Experimental | Drug: Phase 1b: HZBio1 6mgParticipants receive HZBio1 at doses of 6 mg every two weeks for a total of six doses |
| Phase 1b: HZBio1 12 mg | Experimental | Drug: Phase 1b: HZBio1 12mgParticipants receive HZBio1 at doses of 12 mg every two weeks for a total of six doses |
| Phase 2: HZBio1 6 mg | Experimental | Drug: Phase 2: HZBio1 6mgParticipants receive intramuscular injections of HZBio1 at 6 mg every two weeks. Participants receive a total of 14 administrations. |
| Phase 2: HZBio1 9 mg | Experimental | Drug: Phase 2: HZBio1 9mgParticipants receive intramuscular injections of HZBio1 at 9 mg every two weeks. Participants receive a total of 14 administrations. |
| Phase 2: HZBio1 12 mg | Experimental | Drug: Phase 2: HZBio1 12mgParticipants receive intramuscular injections of HZBio1 at 12 mg every two weeks. Participants receive a total of 14 administrations. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (30 listed)
- 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.
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 |
|---|---|---|
| Phase 1b: HZBio1 3mgParticipants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses | Drug | Phase 1b: HZBio1 3 mg |
| Phase 1b: HZBio1 6mgParticipants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses | Drug | Phase 1b: HZBio1 6 mg |
| Phase 1b: HZBio1 12mgParticipants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses | Drug | Phase 1b: HZBio1 12 mg |
| Phase 2: HZBio1 6mgParticipants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations. | Drug | Phase 2: HZBio1 6 mg |
| Phase 2: HZBio1 9mgParticipants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations. | Drug | Phase 2: HZBio1 9 mg |
| Phase 2: HZBio1 12mgParticipants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations. | Drug | Phase 2: HZBio1 12 mg |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: 10 weeks
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase 1b: HZBio1 3mg, Phase 1b: HZBio1 6mg and Phase 1b: HZBio1 12mg in people with Gout, run by Hangzhou Grand Biologic Pharmaceutical, Inc. at 1 site in China.
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 8 inclusion and 30 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: 10 weeks). 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 7 Aug 2026.