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Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPX-101 Low Dose | Experimental | Inhalation Solution twice daily for 7 days. |
|
| SPX-101 Mid Dose | Experimental | Inhalation Solution twice daily for 7 days. |
|
| SPX-101 High Dose | Experimental | Inhalation Solution twice daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPX-101 | Drug | Inhalation solution twice daily for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Day 1 through Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline through Day 8 in percent predicted FEV1 | Screening and Day 1 through Day 8 | |
| Change from baseline through Day 8 in clinical laboratory tests | Chemistry, Hematology, Urinalysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Tullis, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31302339 | Derived | Couroux P, Farias P, Rizvi L, Griffin K, Hudson C, Crowder T, Tarran R, Tullis E. First clinical trials of novel ENaC targeting therapy, SPX-101, in healthy volunteers and adults with cystic fibrosis. Pulm Pharmacol Ther. 2019 Oct;58:101819. doi: 10.1016/j.pupt.2019.101819. Epub 2019 Jul 11. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Screening and Day 1 through Day 8 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |