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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:
Investigator will start with lower doses of IN026 and slowly increase the dose to find the well-tolerated dose.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| IN026 at Dose-Level E | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN026 Injection | Drug | IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion |
|
| Measure | Description | 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) |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of | Contact | +86-27-85726338 | qiubaili@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| QiuBai Li | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| D008659 | Metabolic Diseases |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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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 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. |
|
| 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 |
| D011686 |
| Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |