Systemic Bioactivity of Inhaled Nebulized RNS60

The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the circulation.

Study Overview

• Status: Completed
• Conditions: Systemic Bioactivity of Nebulized RNS60
• Intervention / Treatment: Drug: RNS60; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XP
      • Surrey Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
2. The participant has signed the ICF.
3. Healthy male or female participants aged 18-45 years inclusive. Attempts will be made to achieve an equal gender ratio through appropriate screening procedures, but a failure to do so will not preclude analysis of the final data set.
4. BMI between 19 and 27 kg/m2.
5. The participant is, in the opinion of the investigator, healthy on the basis of medical history and vital signs.
6. Available for follow-up for the duration of the study.
7. Non-smokers (no smoking or use of nicotine replacements (including e-cigarettes) in the previous month before screening or during the study)
8. Agree to abstain from donating blood during the study.
9. Men and women of reproductive potential who document use of adequate contraception during the study and for 1 month following the last day of treatment (Day 23)
10. Willing to refrain from taking anti-inflammatory medications during the study (particularly ibuprofen).

Exclusion Criteria:

1. Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician.
2. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1.
3. History of significant musculoskeletal upper limb injury.
4. Participating in regular (≥ 2 times per week) upper body resistance exercise training within 6 weeks of Visit 1.
5. FEV1 < 80% or FEV1/FEC of < 75%
6. Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of Visit 1.
7. Use of NSAIDs and other OTC medications within 2 weeks of Visit 1.
8. Use of any dietary/nutritional supplements, including vitamins and minerals, in the 2 weeks before Visit 1.
9. Positive urinary pregnancy test.
10. Pregnant or lactating at any point during the study from screening to final visit.
11. Following a weight reducing diet.
12. Currently participating in another clinical trial with an investigational or non-investigational drug or device, or has participated in another clinical trial within the 3 months preceding Visit 1.
13. Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
14. Receipt of blood products or immunoglobin, within 3 months of visit 1.
15. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

No waivers from the Protocol will be allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RNS60; Administration of nebulized RNS60 to test for systemic bioactivity	Drug: RNS60; RNS60, 4 ml dose nebulized twice daily
Placebo Comparator: Normal Saline; Administration of normal saline used as control	Drug: Normal saline; Normal Saline, 4 ml dose nebulized twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Revalesio Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 7, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 18, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Pharmaceutical Solutions; RNS60
• Other Study ID Numbers: 08.1.2.H8