Safety Study of Nebulized RNS60 to Treat Asthma.

Completed · Phase 1

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01057498

Run by

Revalesio Corporation

People needed

36

Starts

2010-05-01

Expected to finish

2011-01-01

Last updated by the study team

2012-01-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For single-dose safety (Groups 1a and 1b):
• Male or female, aged 18 to 65 years.
• 1. For healthy subjects; clinically considered "healthy" and no diagnosis of asthma.
• 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).
• Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent.
• 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.

Where it is running

• West Coast Clinical Trials — Cypress, California, United States
• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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