drugset / Trial / NCT02436447

A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

NCT02436447

Phase 1 Completed 23 enrolled Stealth BioTherapeutics Inc.
Non-randomizedParallel-groupOpen-labelBasic science

Summary

This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.

Timeline

Start
2015-05
Primary completion
2015-07
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Elamipretide Peptide Intravenous