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Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Efficacy of LY-M003 Injection in Adult Patients With Wilson's Disease

NCT07641140 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-02

No results posted yet for this study

Summary

This is a multicenter, open-label, single-arm, single-dose Phase I/II clinical study. It aims to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of LY-M003 Injection in patients with Wilson's Disease (WD).

Conditions

  • Wilson's Disease

Interventions

GENETIC

LY-M003 Injection

Phase 1: Participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 1.The dose for Dose Group 1 is 4.0 × 10¹³ vg/kg.All participants are administered the drug once via intravenous injection.

GENETIC

LY-M003 Injection

Phase 1: Participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at de-escalation dose.The dose for de-escalation dose is 2.0 × 10¹³ vg/kg.All participants are administered the drug once via intravenous injection.

GENETIC

LY-M003 Injection

Phase 2: Participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 1.The dose for dose group 1 is 4.0 × 10¹³ vg/kg.All participants are administered the drug once via intravenous injection.

Sponsors & Collaborators

  • Lingyi Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chaohui Yu, PhD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-12-30
Completion
2032-12-30

Countries

  • China

Study Locations

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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 NCT07641140 on ClinicalTrials.gov