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

NCT02388464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-09-17

No results posted yet for this study

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

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

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
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Drugs

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 NCT02388464 on ClinicalTrials.gov