Safety Study of Nebulized RNS60 to Treat Asthma.

Study Overview
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Brief Summary
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The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.

Official Title
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A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.

Conditions
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Asthma

Intervention / Treatment
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* Drug: RNS60
* Drug: RNS60 - single dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For single-dose safety (Groups 1a and 1b): 1. Male or female, aged 18 to 65 years. 2.1. For healthy subjects; clinically considered healthy and no diagnosis of asthma. 2.2. For subjects with mild asthma, clinical diagnosis of mild chronic asthma as determined by National Heart, Lung, and Blood Institute's (NHLBI) 2007 guidelines, and who are not regularly using a chronic asthma medication (< 3 doses/week). 3. Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent. 4. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry. For multi-dose safety study (Group 2e): Male or female, aged 18 to 65 years. Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication. Historical documentation of asthma in the patient's medical record. 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 28). Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry. Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent. Exclusion Criteria (for all groups of the study): With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy. Pregnancy or lactation. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated). History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV). Infections that require intravenous antibiotic therapy. Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry). Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry. Treatment with any investigational drugs or therapies within 4 weeks prior to study entry. Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days. Group 1b: Any use of oral, systemic corticosteroids within 2 weeks prior to enrollment. Group 2e: Any use of oral, systemic corticosteroids within 4 weeks prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1a - RNS60 in Healthy Subjects<br>Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects. | Drug: RNS60 - single dose<br>* RNS60, single 4 ml dose nebulized for 15 minutes<br>|
| Experimental: 1b: RNS60 in Mild Asthmatics<br>Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics. | Drug: RNS60 - single dose<br>* RNS60, single 4 ml dose nebulized for 15 minutes<br>|
| Experimental: 2e: RNS60 in mild-to-moderate asthmatics<br>RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication. | Drug: RNS60<br>* RNS60, 4ml nebulized twice daily for 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) | Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by weekly FEV1 scores over 28 days. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow | Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by peak expiratory flow measured twice daily over 28 days. | 28 days | 
| Quality of life | Evidence that nebulized RNS60 does not cause a reduced quality of life in subjects with mild-to-moderate asthma, as measured a weekly quality of life questionnaire. | 28 days |