ABOUT THIS STUDY
- Diagnosis of Duchenne muscular dystrophy confirmed by medical history and genetic testing
- Body weight between 15 and 50 kg
- Receipt of glucocorticoids for 6 months and a stable daily dose for at least 3 months prior to study entry
- Ability to rise from floor within seven (7) seconds and ability to walk
- Current exposure to systemic immunosuppressant agents other than glucocorticoids.
- Prior exposure to any gene therapy agent, including exon-skipping and missense agents.
- Exposure to other investigational drugs within 30 days or 5 half-lives, whichever is
- Any injury which may impact functional testing per investigator's judgement. Previous
injuries must be fully healed prior to consenting. Prior lower limb fractures must be
fully healed and at least 3 months from injury date at screening.
- Any planned surgeries which may impact physical activity and performance.
- Presence or history of musculoskeletal or neurological disease in addition to DMD.
- Any known allergies or skin reactions to stainless steel, versaflex, and silicon that
may cause possible discomfort by wearable sensors.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, cancer, autoimmune or allergic
disease that may interfere with the study conduct as per investigator's judgment,
excluding untreated, asymptomatic, seasonal allergies at time of screening.
- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
participants who are Pfizer employees, including their family members, directly
involved in the conduct of the study.
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