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Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics

NCT01537666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-03-31

Study results available
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Summary

The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.

Conditions

Interventions

DRUG

AeroVanc

Vancomycin hydrochloride dry powder for inhalation

DRUG

IV vancomycin hydrochloride

Vancomycin hydrochloride solution for intravenous administration

Sponsors & Collaborators

  • INC Research Limited

    collaborator INDUSTRY

  • Savara Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

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 NCT01537666 on ClinicalTrials.gov