Trials / Completed
CompletedNCT02490865
Systemic Bioactivity of Inhaled Nebulized RNS60
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Revalesio Corporation · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the circulation.
Detailed description
The study is a double-blind, placebo controlled, parallel design study. Participants will be randomized to receive 2 daily doses of either nebulised RNS60 or placebo (n=28 per group) for 22 days. On day 19 they will undergo an exercise protocol to induce muscle damage and blood samples will be taken on days 19, 20, 21 and 23 to determine the effects on CK and hsCRP. ROM and pain VAS assessments will also be completed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RNS60 | RNS60, 4 ml dose nebulized twice daily |
| DRUG | Normal saline | Normal Saline, 4 ml dose nebulized twice daily |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2015-07-07
- Last updated
- 2015-09-22
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02490865. Inclusion in this directory is not an endorsement.