Safety Study of Nebulized RNS60 to Treat Asthma.

Revalesio

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: RNS60 - single dose; Drug: RNS60

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057498

01.1.1.H1

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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):

1. Male or female, aged 18 to 65 years.
2. Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication.
3. Historical documentation of asthma in the patient's medical record.
4. 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).
5. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.
6. 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):

1. With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy.
2. Pregnancy or lactation.
3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated).
4. History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV).
5. Infections that require intravenous antibiotic therapy.
6. 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).
7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.
8. Treatment with any investigational drugs or therapies within 4 weeks prior to study entry.
9. Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days.
10. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

1a - RNS60 in Healthy Subjects

Experimental group

Description:

Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects.

Treatment:

Drug: RNS60 - single dose

1b: RNS60 in Mild Asthmatics

Experimental group

Description:

Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics.

Treatment:

Drug: RNS60 - single dose

2e: RNS60 in mild-to-moderate asthmatics

Experimental group

Description:

RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication.

Treatment:

Drug: RNS60