Study of Safety, PK, and Efficacy of Multiple Ascending Doses of HZBio1 in Patients With Gout

NCT07752810 | Completed Phase 1

• 1 other identifier: YDHY (HZBio1)-001 (Ib/Ⅱ)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. The secondary objectives were to preliminarily explore the PD and immunogenicity of multiple-dose administration of HZBio1.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Study Arms (6)

Phase 1b: HZBio1 3 mg

EXPERIMENTAL

Participants receive HZBio1 at doses of 3 mg every two weeks for a total of six doses

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

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

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.

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.

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.

Drug: Phase 2: HZBio1 12mg

Interventions

Phase 1b: HZBio1 3mg DRUG

Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses

Phase 1b: HZBio1 3 mg

Phase 1b: HZBio1 6mg DRUG

Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses

Phase 1b: HZBio1 6 mg

Phase 1b: HZBio1 12mg DRUG

Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses

Phase 1b: HZBio1 12 mg

Phase 2: HZBio1 6mg DRUG

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 6 mg

Phase 2: HZBio1 9mg DRUG

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 9 mg

Phase 2: HZBio1 12mg DRUG

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 12 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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%).

Sponsors & Collaborators

• Hangzhou Grand Biologic Pharmaceutical, Inc.: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 7, 2026
• Study Start: June 23, 2022
• Primary Completion: December 6, 2024
• Study Completion: May 19, 2025
• Last Updated: August 7, 2026

Record last verified: 2025-05

Locations

CN (1)