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This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled ETD001in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose | Experimental | Single dose of inhaled ETD001/placebo on one occasion |
|
| Multiple ascending dose (7 days) | Experimental | Daily doses of ETD001/placebo for 7 consecutive days |
|
| Multiple ascending dose (14 days) | Experimental | Daily doses of ETD001/placebo for 14 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETD001 single dose | Drug | Single ascending doses of inhaled ETD001 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting one or more treatment emergent adverse event (TEAE) | Baseline to Week 8 | |
| Number of participants who discontinue due to an adverse event (AE) | Baseline to Week 8 | |
| Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose | Baseline to Week 8 | |
| Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose | Baseline to Week 8 | |
| Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose | Baseline to Week 8 | |
| Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of ETD001 | Blood levels of ETD001 measured after dosing | Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niyati Prasad, MD | Enterprise Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
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| Placebo single dose |
| Drug |
Single doses of inhaled placebo |
|
| ETD001 multiple twice daily doses | Drug | Ascending doses of inhaled ETD001 administered twice daily |
|
| Placebo multiple twice daily doses | Drug | Doses of inhaled placebo administered twice daily |
|
| ETD001 multiple once daily doses | Drug | Doses of inhaled ETD001 administered once daily |
|
| Placebo multiple once daily doses | Drug | Doses of inhaled placebo administered once daily |
|
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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