Refractory GoutPhase 1NCT07587684
A Study of IN026 in Participants With Refractory Gout
A Phase 1 study testing IN026 Injection in people with Refractory Gout, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Gout
- What is being tested?
- IN026 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to May 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of contact
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Huazhong University of Science and Technology Union Hospital, Tongji Medical College,, 027-85726685, whuniongcp01@126.com
About this study
Official title: 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?
Read more
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.
- Conditions
- Refractory Gout
- Being tested
- IN026 Injection
- Keywords
- Uricase, Gout, Uric acid, IN026, hyperuricemia, Metabolic Diseases, Refractory Gout, Safety, Pharmacokinetics, Pharmacodynamics, Efficacy, mRNA-LNP medicine, Rheumatic Diseases, Messenger RNA, Urate oxidase, immunogenicity
- Medical subject headings
- Gout, Hyperuricemia, Metabolic Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN026 InjectionDrug
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| IN026 at Dose-Level A | Experimental | 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. Receives: Drug: IN026 Injection |
| IN026 at Dose-Level B | Experimental | 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. Receives: Drug: IN026 Injection |
| IN026 at Dose-Level C | Experimental | 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. Receives: Drug: IN026 Injection |
| IN026 at Dose-Level D | Experimental | 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. Receives: Drug: IN026 Injection |
| 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. Receives: Drug: IN026 Injection |
| IN026 at Dose-Level F | Experimental | 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. Receives: Drug: IN026 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Measured: From first dose (Week 1 Day 1) through end of study (Week 21)
Secondary outcomes (8)
Change from Baseline in Serum Uric Acid Concentration
Measured: From baseline (Week 1 Day 1) through Week 21
Change in Tophi from Baseline
Measured: From baseline (Week 1 Day 1) through Week 21
Plasma Concentration of IN026 mRNA Over Time
Measured: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Plasma Concentration of Ionizable Lipid SX-66 Over Time
Measured: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uricase Level Over Time
Measured: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uric Acid Level Over Time
Measured: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Allantoin Level Over Time
Measured: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Titer of Anti-Drug Antibodies (ADAs) Over Time
Measured: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start12 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- QiuBai Li, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587684
- Sponsor's protocol ID
- IN026-001
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No