NCT01847573

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

A Phase 1b Open Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT-100 in Patients With Duchenne Muscular Dystrophy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Processa Pharmaceuticals · Industry
• Sex: Male
• Age: 6 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	HT-100	May be administered in either fed or fasted state

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-03-30
• Completion: 2016-03-30
• First posted: 2013-05-07
• Last updated: 2020-09-03

Locations

5 sites across 1 country: United States