Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

NCT01333904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2012-09-07

No results posted yet for this study

Summary

The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in sputum and mucociliary clearance.

Conditions

Interventions

DRUG

PUR118

inhaled

Sponsors & Collaborators

  • Quotient Bioresearch

    collaborator INDUSTRY
  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MD · Quotient Bioresearch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01333904 on ClinicalTrials.gov