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Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects

NCT00947687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-09-19

No results posted yet for this study

Summary

The objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.

Conditions

  • Healthy

Interventions

DRUG

PUR003

Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days

DRUG

Placebo

Sponsors & Collaborators

  • Retroscreen Virology Ltd.

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • John P Hanrahan, MD · Pulmatrix Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-09-30
Completion
2009-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT00947687 on ClinicalTrials.gov