Systemic Bioactivity of Inhaled Nebulized RNS60

NCT02490865 | Completed Phase 1

• 1 other identifier: 08.1.2.H8
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Bioactivity of Nebulized RNS60

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

RNS60

EXPERIMENTAL

Administration of nebulized RNS60 to test for systemic bioactivity

Drug: RNS60

Normal Saline

PLACEBO COMPARATOR

Administration of normal saline used as control

Drug: Normal saline

Interventions

RNS60 DRUG

RNS60, 4 ml dose nebulized twice daily

RNS60

Normal saline DRUG

Normal Saline, 4 ml dose nebulized twice daily

Normal Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
• The participant has signed the ICF.
• 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.
• BMI between 19 and 27 kg/m2.
• The participant is, in the opinion of the investigator, healthy on the basis of medical history and vital signs.
• Available for follow-up for the duration of the study.
• Non-smokers (no smoking or use of nicotine replacements (including e-cigarettes) in the previous month before screening or during the study)
• Agree to abstain from donating blood during the study.
• 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)
• Willing to refrain from taking anti-inflammatory medications during the study (particularly ibuprofen).

You may not qualify if:

• 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.
• History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1.
• History of significant musculoskeletal upper limb injury.
• Participating in regular (≥ 2 times per week) upper body resistance exercise training within 6 weeks of Visit 1.
• FEV1 \< 80% or FEV1/FEC of \< 75%
• Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of Visit 1.
• Use of NSAIDs and other OTC medications within 2 weeks of Visit 1.
• Use of any dietary/nutritional supplements, including vitamins and minerals, in the 2 weeks before Visit 1.
• Positive urinary pregnancy test.
• Pregnant or lactating at any point during the study from screening to final visit.
• Following a weight reducing diet.
• 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.
• Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
• Receipt of blood products or immunoglobin, within 3 months of visit 1.
• Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

Sponsors & Collaborators

• Revalesio Corporation: lead

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, GU2 7XP, United Kingdom

Location

MeSH Terms

Interventions

RNS60; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

GB (1)