NCT02388464

A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

A Phase 1 Clinical Pharmacology Study of the Effects of a Single 4 Hour Intravenous Infusion of Bendavia™ (MTP-131) in Subjects With Stable New York Heart Association Class II-III Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	MTP-131	MTP-131 (low dose) administered as single intravenous infusion over 4 hours
DRUG	MTP-131	MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours
DRUG	MTP-131	MTP-131 (high dose) administered as single intravenous infusion over 4 hours
DRUG	Placebo	Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2015-03-17
• Last updated: 2015-09-17

Locations

1 site across 1 country: Bulgaria