NCT07587684招募中1 期

A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2026年6月12日最近更新: 2026年7月31日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 16
试验地点: 1
主要终点: Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments). The main questions it aims to answer are:

What medical problems do participants have when taking IN026, such as changes in vital signs, blood tests, or heart rhythm?
How does the body absorb, process, and respond to IN026, and does it trigger an immune reaction?
Does IN026 lower uric acid levels in the blood and reduce tophi?

Investigator will start with lower doses of IN026 and slowly increase the dose to find the well-tolerated dose.

Participants will:

Receive IN026 through an intravenous (IV) drip into a vein at a set dose.
Complete a screening period of up to 4 weeks, followed by treatment and check-ups for up to 20 weeks.
Have blood and urine samples taken at set times to check safety and how the body responds to IN026.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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)

排除标准

•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.

研究组 & 干预措施

IN026 at Dose-Level E

Experimental

Participants receive intravenous IN026 Injection at dose-level E on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.