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.
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.
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.
Sequential
IN026 Injection
DrugIN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
6
Treatment groupsSee each treatment group below.
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Change from Baseline in Serum Uric Acid Concentration
Change in Tophi from Baseline
Plasma Concentration of IN026 mRNA Over Time
Plasma Concentration of Ionizable Lipid SX-66 Over Time
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This trial is not recruiting at the moment. You can still explore other options:
