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A Study of IN026 in Participants With Refractory Gout

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

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.

研究概览

地位

招聘中

研究类型

介入性

注册 (估计的)

16

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
  • 电话号码:+86-27-85726338
  • 邮箱:qiubaili@hust.edu.cn

学习地点

      • Wuhan、中国
        • 招聘中
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 接触:
          • Huazhong University of Science and Technology Union Hospital, Tongji Medical College,
          • 电话号码:027-85726685
          • 邮箱:whuniongcp01@126.com

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:IN026 at Dose-Level A
Participants receive intravenous IN026 Injection at dose-level A on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
实验性的:IN026 at Dose-Level B
Participants receive intravenous IN026 Injection at dose-level B on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
实验性的:IN026 at Dose-Level C
Participants receive intravenous IN026 Injection at dose-level C on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
实验性的:IN026 at Dose-Level D
Participants receive intravenous IN026 Injection at dose-level D on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
实验性的:IN026 at Dose-Level E
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.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
实验性的:IN026 at Dose-Level F
Participants receive intravenous IN026 Injection at dose-level F on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
大体时间:From first dose (Week 1 Day 1) through end of study (Week 21)
From first dose (Week 1 Day 1) through end of study (Week 21)

次要结果测量

结果测量
大体时间
Change from Baseline in Serum Uric Acid Concentration
大体时间:From baseline (Week 1 Day 1) through Week 21
From baseline (Week 1 Day 1) through Week 21
Change in Tophi from Baseline
大体时间:From baseline (Week 1 Day 1) through Week 21
From baseline (Week 1 Day 1) through Week 21
Plasma Concentration of IN026 mRNA Over Time
大体时间:At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Plasma Concentration of Ionizable Lipid SX-66 Over Time
大体时间:At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uricase Level Over Time
大体时间:At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uric Acid Level Over Time
大体时间:At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Allantoin Level Over Time
大体时间:At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Titer of Anti-Drug Antibodies (ADAs) Over Time
大体时间:At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:QiuBai Li、Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月12日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年5月7日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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