RecruitingEarly Phase 1NCT06650319

A Clinical Study to Evaluate the Safety and Efficacy of LY-M003 Injection in Patients With Wilson Disease

Prospective, Single-center, Open-label, Single-arm, Single-dose Clinical Study to Evaluate the Safety, Tolerability and Efficacy of LY-M003 Injection in Adult and Pediatric Patients With Wilson Disease


Sponsor

Chaohui Yu

Enrollment

18 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Wilson's disease (WD), also known as Wilson's disease, is a rare autosomal recessive metabolic disorder caused by a mutation of the copper transport ATPase β (ATP7B) gene located on the long arm of chromosome 13 (13q14.3). This leads to accumulation of copper ions in multiple organs such as liver, brain and kidney, resulting in organ involvement. In this study, LY-M003 Injection is a gene therapy products with rAAV8 vector. After a single intravenous infusion, LY-M003 can be transduced to the target organ of liver and express the ATP7B in hepatocytese.


Eligibility

Min Age: 10 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying LY-M003 for people with wilson disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 10 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICLY-M003

A single peripheral intravenous (IV) infusion of LY-M003


Locations(1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT06650319


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