Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy

Exclusion Criteria

• •1. Individuals with confirmed comorbidities at the time of screening:
• •* Left ventricular ejection fraction (LVEF) below 50%, as determined by echocardiography
• •* Percent predicted forced vital capacity (FVC%) less than 35%
• •* Positive for Hepatitis B surface antigen (HBsAg). However, individuals undergoing interferon or antiviral treatment can register
• •* Positive for Hepatitis C virus antibody (HCV Ab). Registration is possible if the HCV ribonucleic acid (RNA) test result is negative
• •* Positive for Human immunodeficiency virus (HIV) antibody
• •* Comorbidities that are uncontrollable or require treatment that could affect the safety and efficacy evaluation of this clinical trial, based on the investigator's judgment
• •2. Individuals with confirmed treatment history at the time of screening:
• •* Administration of cell therapy or gene therapy throughout life
• •* Administer antisense oligonucleotide (e.g., exon skipping treatment) or stop- codon readthrough treatment (e.g., aminoglycoside, ataluren) within 24 weeks before screening.
• •* Administration of the following medications within 12 weeks before screening: Idebenone, Resveratrol, Adenosine triphosphate
• •* Administration of the following medications within 12 weeks before screening. However, registration is possible if the drug is being administered at a stable dose for at least 12 weeks before screening and the dose is expected to remain unchanged during the clinical trial period. Angiotensin-converting enzyme (ACE) inhibitor Angiotensin II receptor blocker (ARB) Beta-blocker Aldosterone antagonist Ivabradine Sacubitril Growth hormone Anabolic steroids
• •* Major surgery within 12 weeks before screening or expected major surgery during the clinical trial period.
• •* Use of other investigational products (or medical devices) within 4 weeks before screening.
• •* Use of systemic immunosuppressants other than systemic glucocorticoids.
• •3. Individuals requiring mechanical ventilation during the day.
• •4. Persons with hypersensitivity to the components of the clinical investigational products.
• •5. Individuals unwilling to use appropriate contraception from the date of written consent to the termination visit:
• •* Appropriate contraceptive methods are as follows, and use more than one method.
• •* The use of hormonal contraceptives by the partner
• •* Implantation of an intrauterine device or system in your partner
• •* Sterilization or surgical procedures for you or your partner
• •6. Others who, in the investigator's discretion, are not willing or able to comply with the clinical trial procedures.