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| Name | Class |
|---|---|
| Smerud Medical Research International AS | OTHER |
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Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic duct, and in the reproductive system. The objective of this study is to determine the safety and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled OligoG CF-5/20 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OligoG CF-5/20 | Drug | Inhaled OligoG CF-5/20 will be given to healthy volunteers with different concentrations to test tolerability of the drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and local tolerability of multiple dose administration of inhaled alginate oligosaccharide (OligoG CF-5/20) fragment in healthy volunteers, particular emphasis will be put on pulmonary functioning and pulmonary adverse events. | 3 days dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Febbraro | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merthyr Tydfil | United Kingdom |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C000723800 | oligoG CF-5-20 |
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