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A Clinical Study on the Treatment of Wilson Disease With ATP7B mRNA/LNP (DSL101)

NCT07240896 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-20

No results posted yet for this study

Summary

This study adopted an open, single-arm, non-randomized, dose-escalation research design, aiming to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic and immunogenicity characteristics of single and multiple intravenous infusions of DSL101 in patients with Wilson's disease.

Conditions

  • Wilsons Disease

Interventions

DRUG

Group 1: DSL101 Low dose

Subjects will receive intravenous infusions of DSL101 once every four weeks.

DRUG

Group 2: DSL101 Medium dose

Subjects will receive intravenous infusions of DSL101 once every four weeks.

DRUG

Group 3: DSL101 High dose

Subjects will receive intravenous infusions of DSL101 once every four weeks.

Sponsors & Collaborators

  • DSciLab Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2028-04-30
Completion
2029-04-30

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 NCT07240896 on ClinicalTrials.gov