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NCT01057498 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Nebulized RNS60 to Treat Asthma.
A Phase 1 study, sponsored by Revalesio Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01057498: Completed Phase 1 study, sponsored by Revalesio Corporation.
NCT01057498 is a Phase 1 study that has completed, run by Revalesio Corporation. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01057498, a Phase 1 study, has completed, sponsored by Revalesio Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
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.
Primary Outcome
Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by weekly FEV1 scores over 28 days.
Interventions
- DRUG RNS60
- DRUG RNS60 - single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01057498 record still lists
NCT01057498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which RNS60 is the first listed.
NCT01057498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01057498 about?
NCT01057498 is a clinical study titled "Safety Study of Nebulized RNS60 to Treat Asthma.". 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 pe...
What is the current status of trial NCT01057498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-05. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01057498?
The interventions under investigation include: RNS60 (DRUG), RNS60 - single dose (DRUG).
Who is sponsoring clinical trial NCT01057498?
This trial is sponsored by Revalesio Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01057498's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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