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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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This is a Phase 1 study to learn about the safety and pharmacokinetics of the study drug in patients with asthma and whether the study drug has effect during a respiratory challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADO-5030 | Experimental | This is a single-arm study. All participants will receive ADO-5030. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADO-5030 | Drug | Single oral dose of ADO-5030. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in PC20 AMP. | PC20 AMP is defined as the provocative concentration of AMP resulting in a 20% fall from baseline in FEV1. FEV1 is defined as the amount of air you can forcefully exhale in one second. | As this is a single dose trial, the timeframe is the duration in which PC20 AMP is reached during the AMP Challenge with ADO-5030 on Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ADO-5030 Treatment-Emergent Adverse Events (TEAEs). | TEAEs are defined as all adverse events (AEs) that subjects report after the administration of ADO-5030. Frequency of TEAEs will be reported. | Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose. |
| Severity of ADO-5030 Treatment-Emergent Adverse Events (TEAEs). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Murphy, BSN | Contact | 434-982-3510 | ddm9q@uvahealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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TEAEs are defined as all adverse events (AEs) that subjects report after the administration of ADO-5030. Severity of TEAEs will be reported. |
| Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose. |
| Frequency of ADO-5030 Treatment-Related Adverse Events (TRAEs). | TRAEs are defined as adverse events (AEs) that subjects report after the administration of ADO-5030, and that are deemed related to ADO-5030 by the principal investigator (PI). Frequency of TRAEs will be reported. | Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose. |
| Severity of ADO-5030 Treatment-Related Adverse Events (TRAEs). | TRAEs are defined as adverse events (AEs) that subjects report after the administration of ADO-5030, and that are deemed related to ADO-5030 by the principal investigator (PI). Severity of TRAEs will be reported. | Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose. |
| Frequency of Adverse Events (AEs). | The frequency of all AEs reported by subjects will be reported. | Enrollment to End of Study, assessed up to 9 days post-dose. |
| Severity of Adverse Events (AEs). | The severity of all AEs reported by the subject will be reported. | Enrollment to End of Study, assessed up to 9 days post-dose. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |