A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
qiubaili@hust.edu.cn
+86-27-85726338
Time Frame
Start Date:2026-06-12
Estimated Completion Date:2028-05
Participants
Target number of participants:16
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.