Safety Study of Nebulized RNS60 to Treat Asthma.

NCT01057498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-01-12

No results posted yet for this study

Summary

The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.

Conditions

Interventions

DRUG

RNS60

RNS60, 4ml nebulized twice daily for 15 minutes.

DRUG

RNS60 - single dose

RNS60, single 4 ml dose nebulized for 15 minutes

Sponsors & Collaborators

  • Revalesio Corporation

    lead INDUSTRY

Principal Investigators

  • Kari C Nadeau, M.D., Ph.D. · Stanford University

  • Richard L Watson, M.D. · Revalesio Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-11-30
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01057498 on ClinicalTrials.gov