Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy
Stopped early · Phase 1/Phase 2
Conditions studied: Duchenne Muscular Dystrophy
In brief
The main purpose of this study is to test the safety and tolerability of different, increasing doses of an experimental medication called HT-100 in boys and young men with Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help promote healthy muscle regeneration, diminish inflammation and the resulting damage to muscle, and decrease the scar tissue that forms in the muscles of children with DMD. In this study, pharmacokinetic sampling, or measurements of the amount of HT-100 in the bloodstream will also be taken.
Key facts
- Study ID
- NCT01847573
- Run by
- Processa Pharmaceuticals
- People needed
- 17
- Starts
- 2013-05-01
- Expected to finish
- 2016-03-30
- Last updated by the study team
- 2020-09-03
Who can join
Age: 6 and older, up to 20. Sex: male. Healthy volunteers: not accepted.
Where it is running
- University of California, Davis Medical Center — Sacramento, California, United States
- Kennedy Krieger Institute, Johns Hopkins School of Medicine — Baltimore, Maryland, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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