drugset / Trial / NCT01847573

Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy

NCT01847573 ↗

Phase 1/2 Terminated 17 enrolled Processa Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-05
Primary completion
2016-03-30
Completion
2016-03-30

Outcome

Outcome not reported

Stopped: “Dosing stopped”

Drugs

EvaluationDrugModalityDoseRoute
Subject halofuginone Small molecule — —