A Study of IN026 in Participants With Refractory Gout

Inclusion criteria

• Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.
• Male or female, 18-75 years old (inclusive) at screening.
• Meet 2015 ACR/EULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.
• Serum uric acid ≥420 μmol/L (7 mg/dl) at screening.
• Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)

Exclusion criteria

• Gout secondary to radiotherapy/chemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening/baseline.
• Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis at screening/baseline.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.
• Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.
• Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.
• Participants with a history of any of the following: serious cardiovascular diseases within 6 months prior to screening; or serious diseases of the digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematological, or immune systems within 3 months prior to screening.
• Prolonged QTcF at screening.
• Uncontrolled or untreated hypertension at screening.
• Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.
• History of severe allergy, or known allergy to IN026 or its components.
• Participation in other clinical trials within 30 days prior to screening.
• Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.