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

NCT02388529 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-10-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Jim Carr, PharmD · Stealth BioTherapeutics Inc.

  • Sotir Marchev, MD,PhD, FESC · Bulgaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • Bulgaria

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388529 on ClinicalTrials.gov