Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001080-92 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose | Experimental |
| |
| Repeat dose - 7 days | Experimental |
| |
| Repeat dose - 14 days | Experimental |
| |
| Repeat dose - 7 days with SABA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETD002 - single dose | Drug | Single ascending doses of ETD002 |
| |
| 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 safety 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 ETD002 | Blood levels of ETD002 measured after dosing | Day 1 pre-dose and at multiple time points (up to 14 days) post final dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Morris, MD | Enterprise Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41318901 | Derived | Miller P, Repplinger D, Zhu R, Chen Y, Lewin-Koh N, Morris D, Russell P, She G, Singh N, White R, Wilkes D, Chen H, Galanter J. Randomized, phase I studies to evaluate the safety, tolerability, and pharmacokinetics of an inhaled, TMEM16A potentiator, GDC-6988, in healthy subjects. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251393346. doi: 10.1177/17534666251393346. Epub 2025 Nov 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo - single dose |
| Drug |
Single doses of placebo |
|
| ETD002 - 7 day repeat dose | Drug | Twice daily doses of ETD002 for 7 days |
|
| Placebo - 7 day repeat dose | Drug | Twice daily doses of Placebo for 7 days |
|
| ETD002 - 14 day repeat dose | Drug | Twice daily doses of ETD002 for 14 days |
|
| Placebo - 14 day repeat dose | Drug | Twice daily doses of Placebo for 14 days |
|
| Salbutamol | Drug | Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7) |
|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided