Systemic Bioactivity of Inhaled Nebulized RNS60

Revalesio

Status and phase: Completed; Phase 1

Conditions: Systemic Bioactivity of Nebulized RNS60

Treatments: Drug: RNS60; Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02490865

08.1.2.H8

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

RNS60

Experimental group

Description:

Administration of nebulized RNS60 to test for systemic bioactivity

Treatment:

Drug: RNS60

Normal Saline

Placebo Comparator group

Description:

Administration of normal saline used as control

Treatment:

Drug: Normal saline