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A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of BBM-D101 in the Treatment of Duchenne Muscular Dystrophy.

NCT07058662 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-12-04

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-D101 to treat participants with Duchenne Muscular Dystrophy.

Conditions

Interventions

GENETIC

Single dose intravenous of BBM-D101

BBM-D101 is a gene addition therapy based on engineered AAV delivery therapeutic protein gene cassette into muscle for treating DMD. Therapeutic protein could mediate the dystrophin-associated protein complex to prevent muscular dystrophy and to rescue the function of muscle.The administration is completed by a single intravenous infusion.

Sponsors & Collaborators

  • Shanghai Mianyi Biopharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Shanghai Xinzhi BioMed Co., Ltd.

    collaborator INDUSTRY

  • Belief BioMed Limited

    collaborator UNKNOWN

  • Belief BioMed (Beijing) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yi Dai, MD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-06-30
Completion
2031-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07058662 on ClinicalTrials.gov