NCT02388529

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

A Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Due to Reduced Left Ventricular Ejection Fraction

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, randomized, double-blind, placebo-controlled study in patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	MTP-131	MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
DRUG	MTP-131	MTP-131 (intermediate dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
DRUG	MTP-131	MTP-131 (high dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
DRUG	Placebo	Placebo Comparator (at each dose cohort) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-03-17
• Last updated: 2015-10-15

Locations

1 site across 1 country: Bulgaria