drugset
drugset / Trial / NCT02367014

Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

NCT02367014 ↗

Phase 1/2 Completed 36 enrolled Stealth BioTherapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient population.

Timeline

Start
2015-02
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Elamipretide Peptide 0.01 mg/kg Intravenous
Subject Elamipretide Peptide 0.1 mg/kg Intravenous
Subject Elamipretide Peptide 0.25 mg/kg Intravenous

Indications

pure mitochondrial myopathy