Actively Recruiting

Early Phase 1
Age: 4Years - 8Years
MALE
NCT06900049

Evaluation of the Safety, Tolerability, and Efficacy of LE051 in Patients With Duchenne Muscular Dystrophy

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-04-02

12

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LE051 intravenous therapy in DMD patients treated with exon 51 skipping therapy.

CONDITIONS

Official Title

Evaluation of the Safety, Tolerability, and Efficacy of LE051 in Patients With Duchenne Muscular Dystrophy

Who Can Participate

Age: 4Years - 8Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, 4 to 8 years old at the start of screening
  • Clinical diagnosis of Duchenne Muscular Dystrophy confirmed by genetic testing applicable to exon 51 skipping
  • Voluntary participation with comprehension and signed informed consent by the subject or guardian
Not Eligible

You will not qualify if you...

  • Signs of heart failure with left ventricular ejection fraction below 40%
  • Average forced vital capacity less than 40% of the predicted value
  • QT interval corrected (QTc) longer than 0.45 seconds on 12-lead ECG

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

J

Jiwen Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Evaluation of the Safety, Tolerability, and Efficacy of LE051 in Patients With Duchenne Muscular Dystrophy | DecenTrialz