Wilson DiseaseEarly Phase 1WDNCT06650319
A Clinical Study to Evaluate the Safety and Efficacy of LY-M003 Injection in Patients With Wilson Disease
A Early Phase 1 study testing LY-M003 in people with Wilson Disease, run by Chaohui Yu at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Wilson Disease
- What is being tested?
- LY-M003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2024to 30 Mar 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The subject must be able to fully understood the purpose, nature, method, and possible adverse effects of the study, must be able to voluntarily participate in the study and voluntarily able to provide the written informed consent form (ICF).
- Patients diagnosed with Wilson Disease .
- Wilson Disease (WD) patients confirmed by laboratory tests to have biallelic mutations in the ATP7B gene.
- Subjects must be treatment-experienced to WD who have received standard treatment (eg, D-penicillamine or zinc acetate) for at least 6 months prior to the screening period.
- Subjects must restrict food with high copper content for at least 6 months prior to screening and continue this restriction during the entire duration of study participation.
- Subjects must be willing to refrain from donating blood, organs, tissues or cells during study participation.
- Negative pregnancy test in women of childbearing potential (WOCBP).
- Subjects and their partners who have no childbearing plans from the screening period to 6 months after the end of the study and are willing to adopt effective contraceptive measures (e.g., abstinence, condoms, etc.); subjects have no plans to donate sperm or ova.
Who cannot join
- AAV8 neutralizing antibody titer > 1:10 .
- Active gastrointestinal bleeding within the past 3 months.
- Decompensated cirrhosis or advanced hepatic disease, manifested as portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, etc.
- Subjects with other liver diseases as determined by the investigator, such as immune hepatitis, alcoholic liver disease, primary biliary cholangitis, primary sclerosing cholangitis, and/or drug or toxic liver disease
- Subjects considered as complicated with severe hypersplenism and requiring splenectomy as judged by the investigator.
- Model for End-Stage Liver Disease (MELD) Score > 13.
Show all 26Show fewer
- Other disorders of copper metabolism, such as chronic cholestatic liver diseases, disorders of glycosylation, copper metabolism disorders, etc.
- History of noncompliance with copper chelators or zinc agents within 6 months prior to screening, as determined by the investigator.
- Subjects with treatment-experienced WD who have ALT and/or AST 5 times greater than the upper limit of normal (ULN).
- Severe central nervous system symptoms urgent for intensive hospitalization judged by the investigator.
- Hemoglobin < 90 g/L.
- A history of epileptic seizures or other diseases that may potentially affect compliance with study procedures within 6 months prior to the screening period.
- Hepatitis B surface antigen (HBsAg) positive, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive or Treponema pallidum antibody positive.
- Subjects with end-stage renal disease receiving dialysis (chronic kidney disease stage 3 and above) or creatinine clearance < 60 mL/min.
- Severe hyperlipidemia (triglycerides > 1000 mg/dL).
- Subject received or plans to receive bone marrow transplantation, hematopoietic stem cell transplantation and/or major organ transplantation, including but not limited to liver transplantation, kidney transplantation, etc.
- Clinically diagnosed or judged as serious cardiovascular disease by the investigator (eg, classification of heart failure ≥ 3 according to New York Heart Association [NYHA]).
- Patients with uncontrolled concomitant diseases or infectious diseases as judged by the investigator.
- Subjects who have hypersensitivity to any component of LY-M003 injection.
- Subjects who have previously received gene therapy or cell therapy of any kind.
- Subjects who use systemic immunosuppressive agents or receive steroid therapy within 3 months prior to dosing (except for prophylactic immunosuppressive therapy as specified in protocol).
- Subjects with history of cancer within 5 years prior to screening, except for completely resected non-melanoma skin cancer, non-metastatic prostate cancer and completely cured ductal carcinoma in situ.
- Subjects who have vaccinated with attenuated live vaccine within 4 months prior to screening or plan to receive a live attenuated vaccine during the clinical trial.
- Subjects who have received treatment or disposition with another investigational drug or investigational device within 28 days or 5 half-lives (drug only), whichever is longer, prior to screening.
- Pregnant women (or women planning to become pregnant) or lactating women.
- Other circumstances in which the investigator deems the subject inappropriate for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 312000
Chaohui Yu, PhD, 86+13957161659, ych623@sina.com
Yi Chen, PhD, 86+13735536389, yiiic@126.com
About this study
Official title: 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
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.
Read the detailed description
This study adopts a prospective, single-center, open, single-arm, single-dose clinical design to evaluate the safety, tolerability, efficacy, immunogenicity, PD and PK characteristics of LY-M003 injection in WD patients, including the main study phase and the long-term follow-up study phase.
This study is designed with 4 dose groups and 2 cohorts (adult cohort and pediatric cohort), namely: Dose Group 1 (1.0 × 10¹³ vg/kg), Dose Group 2 (2.0 × 10¹³ vg/kg), Dose Group 3 (4.0 × 10¹³ vg/kg) and Dose Group 4 (6.0 × 10¹³ vg/kg). Among them, Dose Group 1 serves as the starting dose of this study. The decision to escalate to the 4th dose group shall be made by the investigators and collaborators based on the accumulated safety, efficacy and other relevant data. Based on the accumulated efficacy and safety data of enrolled adult subjects, the investigator and collaborators will determine the starting dose, subsequent enrollment doses, and the number of enrolled cases for pediatric subjects.
- Conditions
- Wilson Disease
- Being tested
- LY-M003
- Keywords
- Gene therapy
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY-M003Genetic
A single peripheral intravenous (IV) infusion of LY-M003
| Study group | Role | What they receive |
|---|---|---|
| LY-M003 Dose group 1-Adult Cohort | Experimental | Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 1. Receives: Genetic: LY-M003 |
| LY-M003 Dose group 2-Adult Cohort | Experimental | Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 2. Receives: Genetic: LY-M003 |
| LY-M003 Dose group 3-Adult Cohort | Experimental | Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 3. Receives: Genetic: LY-M003 |
| LY-M003 Dose group 4-Adult Cohort | Experimental | Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 4. Receives: Genetic: LY-M003 |
| LY-M003-Pediatric Cohort | Experimental | Based on the accumulated efficacy and safety data of enrolled adult subjects, the investigator and collaborators will determine the starting dose, subsequent enrollment doses for pediatric participants. Receives: Genetic: LY-M003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) within 52 weeks after the injection of LY-M003
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From enrollment to 52 weeks after administration
Incidence of dose-limiting toxicity (DLT) events assessed within at least 28 days following LY-M003 infusion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.The adverse events defined as dose-limiting toxicity (DLT) have been clearly specified in the protocol.
Measured: From enrollment to 52 weeks after administration
Secondary outcomes (12)
Percentage decrease in standard of care (SoC) medication use within 52 weeks after administration
To assess the reduction in standard of care (SoC) medication use in subjects who completed administration of LY-M003 injection.
Measured: From enrollment to 52 weeks after administration
Number and proportion of subjects who discontinue standard of care medication within 52 weeks after administration
To evaluate the number and proportion of subjects who complete the administration of LY-M003 injection and discontinued standard of care (SOC) drugs.
Measured: From enrollment to 52 weeks after administration
Change from baseline in serum ceruloplasmin content level through 52 weeks after administration
To assess from baseline in serum ceruloplasmin content level through 52 weeks afterinjection of LY-M003.
Measured: From enrollment to 52 weeks after administration
Change from baseline in total serum copper level through 52 weeks after administrationfrom
To assess change from baseline in total serum copper level through 52 weeks after injection of LY-M003.
Measured: From enrollment to 52 weeks after administration
Change from baseline in serum non-ceruloplasmin-bound copper (NCC) through 52 weeks after administration
To assess change from baseline in serum non-ceruloplasmin-bound copper (NCC) through 52 weeks after injection of LY-M003.
Measured: From enrollment to 52 weeks after administration
Change from baseline in 24-hour urinary copper Concentration through 52 weeks after administration
To assess change from baseline in 24-hour urinary copper Concentration through 52 weeks after injection of LY-M003.
Measured: From enrollment to 52 weeks after administration
Change from baseline in serum ceruloplasmin activity level through 52 weeks after administration
To assess change from baseline in serum ceruloplasmin activity level through 52 weeks after injection of LY-M003.
Measured: From enrollment to 52 weeks after administration
Assessment of the change from baseline in neurological subscale of the Unified Wilson Disease Rating Scale (UWDRS) through 52 weeks after administration.
Assessment of the score change from baseline via the evaluation of neurological subscale of the Unified Wilson Disease Rating Scale (UWDRS).
Measured: From enrollment to 52 weeks after administration
Assessment of the change from baseline in hepatic subscale of the Unified Wilson Disease Rating Scale (UWDRS) through 52 weeks after administration
Assessment of the score change from baseline via the evaluation of hepatic subscale of the Unified Wilson Disease Rating Scale (UWDRS).
Measured: From enrollment to 52 weeks after administration
Assessment of the change from baseline in psychiatric subscale of the Unified Wilson Disease Rating Scale (UWDRS) through 52 weeks after administration
Assessment of the score change from baseline via the evaluation of psychiatric subscale of the Unified Wilson Disease Rating Scale (UWDRS).
Measured: From enrollment to 52 weeks after administration
Change from baseline in liver elasticity through 52 weeks after administration
Assessment of the change in liver elasticity from baseline in subjects via detection with hepatobiliary color Doppler ultrasound combined with ultrasound elastography.
Measured: From enrollment to 52 weeks after administration
Change from baseline in Kayser-Fleischer (K-F) rings through 52 weeks after administration
Evaluation of the change in Kayser-Fleischer (K-F) ring grade from baseline via slit-lamp examination of the eye.
Measured: From enrollment to 52 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start24 Sep 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaohui Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chaohui Yu, First Affiliated Hospital of Zhejiang University
- Investigators
- Chaohui Yu, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650319
- Sponsor's protocol ID
- LY-M003-WD-IIT-002
- Acronym
- WD
- Status last verified
- Jan 2026
- First submitted
- 15 Oct 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is in its early stages and will consider releasing data and related information when detailed and sufficient safety and efficacy data are available in subjects.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06650319
- Acronym / sponsor ID
- WD / LY-M003-WD-IIT-002
- Conditions
- Wilson Disease
- Keywords
- Gene therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chaohui YuUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study adopts a prospective, single-center, open, single-arm, single-dose clinical design to evaluate the safety, tolerability, efficacy, immunogenicity, PD and PK characteristics of LY-M003 injection in WD patients, including the main study phase and the long-term follow-up study phase.
This study is designed with 4 dose groups and 2 cohorts (adult cohort and pediatric cohort), namely: Dose Group 1 (1.0 × 10¹³ vg/kg), Dose Group 2 (2.0 × 10¹³ vg/kg), Dose Group 3 (4.0 × 10¹³ vg/kg) and Dose Group 4 (6.0 × 10¹³ vg/kg). Among them, Dose Group 1 serves as the starting dose of this study. The decision to escalate to the 4th dose group shall be made by the investigators and collaborators based on the accumulated safety, efficacy and other relevant data. Based on the accumulated efficacy and safety data of enrolled adult subjects, the investigator and collaborators will determine the starting dose, subsequent enrollment doses, and the number of enrolled cases for pediatric subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LY-M003 Dose group 1-Adult Cohort | Experimental | Genetic: LY-M003Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 1. |
| LY-M003 Dose group 2-Adult Cohort | Experimental | Genetic: LY-M003Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 2. |
| LY-M003 Dose group 3-Adult Cohort | Experimental | Genetic: LY-M003Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 3. |
| LY-M003 Dose group 4-Adult Cohort | Experimental | Genetic: LY-M003Adult participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 4. |
| LY-M003-Pediatric Cohort | Experimental | Genetic: LY-M003Based on the accumulated efficacy and safety data of enrolled adult subjects, the investigator and collaborators will determine the starting dose, subsequent enrollment doses for pediatric participants. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- The subject must be able to fully understood the purpose, nature, method, and possible adverse effects of the study, must be able to voluntarily participate in the study and voluntarily able to provide the written informed consent form (ICF).
- Patients diagnosed with Wilson Disease .
- Wilson Disease (WD) patients confirmed by laboratory tests to have biallelic mutations in the ATP7B gene.
- Subjects must be treatment-experienced to WD who have received standard treatment (eg, D-penicillamine or zinc acetate) for at least 6 months prior to the screening period.
- Subjects must restrict food with high copper content for at least 6 months prior to screening and continue this restriction during the entire duration of study participation.
Key exclusion criteria (26 listed)
- AAV8 neutralizing antibody titer > 1:10 .
- Active gastrointestinal bleeding within the past 3 months.
- Decompensated cirrhosis or advanced hepatic disease, manifested as portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, etc.
- Subjects with other liver diseases as determined by the investigator, such as immune hepatitis, alcoholic liver disease, primary biliary cholangitis, primary sclerosing cholangitis, and/or drug or toxic liver disease
- Subjects considered as complicated with severe hypersplenism and requiring splenectomy as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY-M003A single peripheral intravenous (IV) infusion of LY-M003 | Genetic | LY-M003 Dose group 1-Adult Cohort, LY-M003 Dose group 2-Adult Cohort, LY-M003 Dose group 3-Adult Cohort, LY-M003 Dose group 4-Adult Cohort, LY-M003-Pediatric Cohort |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) within 52 weeks after the injection of LY-M003
Time frame: From enrollment to 52 weeks after administration
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Incidence of dose-limiting toxicity (DLT) events assessed within at least 28 days following LY-M003 infusion
Time frame: From enrollment to 52 weeks after administration
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.The adverse events defined as dose-limiting toxicity (DLT) have been clearly specified in the protocol.
12 secondary outcomes
Percentage decrease in standard of care (SoC) medication use within 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Number and proportion of subjects who discontinue standard of care medication within 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Change from baseline in serum ceruloplasmin content level through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Change from baseline in total serum copper level through 52 weeks after administrationfrom
Time frame: From enrollment to 52 weeks after administration
Change from baseline in serum non-ceruloplasmin-bound copper (NCC) through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Change from baseline in 24-hour urinary copper Concentration through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Change from baseline in serum ceruloplasmin activity level through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Assessment of the change from baseline in neurological subscale of the Unified Wilson Disease Rating Scale (UWDRS) through 52 weeks after administration.
Time frame: From enrollment to 52 weeks after administration
Assessment of the change from baseline in hepatic subscale of the Unified Wilson Disease Rating Scale (UWDRS) through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Assessment of the change from baseline in psychiatric subscale of the Unified Wilson Disease Rating Scale (UWDRS) through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Change from baseline in liver elasticity through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Change from baseline in Kayser-Fleischer (K-F) rings through 52 weeks after administration
Time frame: From enrollment to 52 weeks after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. The study is in its early stages and will consider releasing data and related information when detailed and sufficient safety and efficacy data are available in subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chaohui Yu, PhD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LY-M003 in people with Wilson Disease, run by Chaohui Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaohui Yu, PhD (86+13957161659, ych623@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) within 52 weeks after the injection of LY-M003 (time frame: From enrollment to 52 weeks after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.