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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1a - RNS60 in Healthy Subjects | Experimental | Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects. |
|
| 1b: RNS60 in Mild Asthmatics | Experimental | Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics. |
|
| 2e: RNS60 in mild-to-moderate asthmatics | Experimental | RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNS60 | Drug | RNS60, 4ml nebulized twice daily for 15 minutes. |
| |
| 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 |
| 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 |
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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):
Exclusion Criteria (for all groups of the study):
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| Name | Affiliation | Role |
|---|---|---|
| Kari C Nadeau, M.D., Ph.D. | Stanford University | Principal Investigator |
| Richard L Watson, M.D. | Revalesio Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Cypress | California | 90630 | United States | ||
| Stanford University |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000627108 | RNS60 |
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| RNS60 - single dose |
| Drug |
RNS60, single 4 ml dose nebulized for 15 minutes |
|
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 |
| Stanford |
| California |
| 94304 |
| United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |