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The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the circulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNS60 | Experimental | Administration of nebulized RNS60 to test for systemic bioactivity |
|
| Normal Saline | Placebo Comparator | Administration of normal saline used as control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNS60 | Drug | RNS60, 4 ml dose nebulized twice daily |
| |
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum concentration of creatine kinase (CK) | 4 days post exercise | |
| Change in serum concentration of highly sensitive C-reactive protein (hsCRP) | 4 days post exercise |
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Inclusion Criteria:
Exclusion Criteria:
No waivers from the Protocol will be allowed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey Clinical Research Centre | Guildford | Surrey | GU2 7XP | United Kingdom |
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| ID | Term |
|---|---|
| C000627108 | RNS60 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
Normal Saline, 4 ml dose nebulized twice daily |
|