Trial Profile
A 3-part, Randomized, Double Blind, Adaptive Seamless Phase 1-3 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of BIO101 in Non-Ambulatory Patients with a Genetically Confirmed Diagnosis of Duchenne Muscular Dystrophy and Evidence of Respiratory Deterioration
Status:
Recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 21 Apr 2023
Price :
$35
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At a glance
- Drugs Sarconeos (Primary)
- Indications Duchenne muscular dystrophy
- Focus Proof of concept; Therapeutic Use
- Acronyms MYODA-PK
- Sponsors Biophytis
- 18 Apr 2023 According to a Biophytis media release, the company thoroughly revised the protocol and propose a phase 1/2 study for non-ambulatory DMD patients with signs of deteriorating lung function. The company expect to submit this new protocol to the competent authorities in the second half of 2023.
- 22 Oct 2021 Planned End Date changed to 23 Mar 2023.
- 22 Oct 2021 Status changed from planning to recruiting.