Safety Study of Nebulized RNS60 to Treat Asthma.
NCT01057498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2012-01-12
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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