NCT02490865已完成1 期
Systemic Bioactivity of Inhaled Nebulized RNS60
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in serum concentration of creatine kinase (CK)
研究概览
简要总结
The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the circulation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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).
排除标准
- •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
- •History of significant musculoskeletal upper limb injury.
- •Participating in regular (≥ 2 times per week) upper body resistance exercise training within 6 weeks of Visit
- •FEV1 < 80% or FEV1/FEC of < 75%
- •Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of Visit
- •Use of NSAIDs and other OTC medications within 2 weeks of Visit
- •Use of any dietary/nutritional supplements, including vitamins and minerals, in the 2 weeks before Visit
- •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
- •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
- •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.
研究组 & 干预措施
RNS60
Experimental
Administration of nebulized RNS60 to test for systemic bioactivity
干预措施: RNS60 (Drug)
Normal Saline
Placebo Comparator
Administration of normal saline used as control
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in serum concentration of creatine kinase (CK)
时间窗: 4 days post exercise
Change in serum concentration of highly sensitive C-reactive protein (hsCRP)
时间窗: 4 days post exercise
次要结局
未报告次要终点
研究者
研究点 (1)
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