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A Study of IN026 in Participants With Refractory Gout

NCT07587684 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Refractory Gout

Interventions

DRUG

IN026 Injection

IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • QiuBai Li · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-08-31
Completion
2028-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587684 on ClinicalTrials.gov