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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Gout
• Intervention / Treatment: Drug: IN026 Injection

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of; Phone Number: +86-27-85726338; Email: qiubaili@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: IN026 Injection; IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
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.	Drug: IN026 Injection; IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
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.	Drug: IN026 Injection; IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
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.	Drug: IN026 Injection; IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
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.	Drug: IN026 Injection; IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
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.	Drug: IN026 Injection; IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)	From first dose (Week 1 Day 1) through end of study (Week 21)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Principal Investigator: QiuBai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Pharmacokinetics; immunogenicity; Rheumatic Diseases; Gout; Uric acid; Messenger RNA; Pharmacodynamics; Metabolic Diseases; hyperuricemia; Uricase; IN026; Refractory Gout; mRNA-LNP medicine; Urate oxidase
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Connective Tissue Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Gout; Hyperuricemia; Metabolic Diseases; Rheumatic Diseases
• Other Study ID Numbers: IN026-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No