Safety Study of Nebulized RNS60 to Treat Asthma.

NCT ID: NCT01057498

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1a - RNS60 in Healthy Subjects

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

Group Type: EXPERIMENTAL

RNS60 - single dose

Intervention Type: DRUG

RNS60, single 4 ml dose nebulized for 15 minutes

1b: RNS60 in Mild Asthmatics

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

Group Type: EXPERIMENTAL

RNS60 - single dose

Intervention Type: DRUG

RNS60, single 4 ml dose nebulized for 15 minutes

2e: RNS60 in mild-to-moderate asthmatics

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

Group Type: EXPERIMENTAL

RNS60

Intervention Type: DRUG

RNS60, 4ml nebulized twice daily for 15 minutes.

Interventions

RNS60

RNS60, 4ml nebulized twice daily for 15 minutes.

Intervention Type: DRUG

RNS60 - single dose

RNS60, single 4 ml dose nebulized for 15 minutes

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Revalesio Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari C Nadeau, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Richard L Watson, M.D.

Role: STUDY_DIRECTOR

Revalesio Corporation

Locations

West Coast Clinical Trials

Cypress, California, United States

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

01.1.1.H1

Identifier Type: -

Identifier Source: org_study_id