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The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

NCT01518985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-04-19

No results posted yet for this study

Summary

This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Bendavia

Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours

DRUG

Sterile saline (0.9%)

Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours

OTHER

Cigarette smoking

One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth C Lasseter, MD · Clinical Pharmacology of Miami

  • Richard Straube, MD · Stealth Peptides

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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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 NCT01518985 on ClinicalTrials.gov