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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001027-13 | EudraCT Number |
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This study has two parts. The main purpose of Part 1 of this study will be to examine how safe and effective two doses of SelK2 is on participants with mild asthma. Lung function and inflammatory cell numbers will be measured in response to the administration of an allergen (a compound to which the participant is allergic) into the lungs in the presence or absence of SelK2. Part 2 of this study will examine how safe and effective one dose of SelK2 is on participants with chronic obstructive pulmonary disease (COPD). Lung function and inflammatory cell numbers will be measured in COPD patients in the presence or absence of SelK2. SelK2 may block the movement of key inflammatory cells into the lungs and consequently improve lung function in these two patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SelK2 (Part 1) | Experimental | I.V., multiple-dose (Day 1 and Day 22) |
|
| Placebo (Part 1) | Placebo Comparator | I.V., multiple-dose (Day 1 and Day 22) |
|
| SelK2 (Part 2) | Experimental | I.V., single-dose (Day 1) |
|
| Placebo (Part 2) | Placebo Comparator | I.V., single-dose (Day 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SelK2 (Part 1) | Drug | I.V., multiple-dose (Day 1 and Day 22) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum percentage fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after administration of allergen inhalation challenge (Part 1). | Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge | |
| Change from baseline in percentage of neutrophils in sputum (Part 2). | Change from baseline to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC for the percent fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after the administration of allergen inhalation challenge (Part 1). | Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge | |
| Change from baseline and change during challenge in percentage of eosinophils in sputum (Part 1) |
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Part 1:
Key Inclusion Criteria
Key Exclusion Criteria
Part 2:
Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Stocker, Ph.D. | Tetherex Pharmaceuticals Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Anne Street Medical Centre | London | United Kingdom | ||||
| Medicines Evaluation Unit Ltd. |
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Part 1 of the study will enroll patients in two arms in a 1:1 ratio to receive either SelK2 or placebo. Part 2 of the study will enroll patients in two arms in a 2:1 ratio to receive either SelK2 or placebo, respectively.
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| Placebo (Part 1) |
| Drug |
I.V., multiple-dose (Day 1 and Day 22) |
|
| SelK2 (Part 2) | Drug | I.V., single-dose (Day 1) |
|
| Placebo (Part 2) | Drug | I.V., single-dose (Day 1) |
|
| Change from baseline to 8 and 24 hours post allergen challenge |
| Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 from pre-challenge between 0 and 2 hours after the administration of allergen inhalation challenge (EAR) (Part 1). | Pre-challenge to between 0 and 2 hours after the administration of allergen inhalation challenge |
| Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 between 0 and 8 hours (entire asthmatic response) after the administration of allergen inhalation challenge (Part 1) | Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge |
| Change from baseline in pre-challenge FEV1 (Part 1). | Change from baseline to Day 29 |
| Change from baseline in percentage of neutrophils (Part 2). | Change from baseline to Days 4, 8, 15, and 29 |
| Change from baseline in absolute and percentage cell counts for immune cells in induced sputum samples and blood (Part 2). | Change from baseline to Days 4, 8, 15, 22, and 29 |
| Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2). | Change from baseline to Days 4, 8, 15, 22, and 29 |
| Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2). | Change from baseline to Days 4, 8, 15, 22, and 29 |
| Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2). | Change from baseline to Days 4, 8, 15, 22, and 29 |
| Change from baseline in COPD Assessment Test (CAT) scores (Part 2). | Scores range from 0-40 with 40 being associated with the worst outcome. | Change from baseline to Days 4, 8, 15, 22, and 29 |
| Change from baseline in Breathlessness Cough and Sputum Scale (BCSS) scores (Part 2). | Scores range from 0-12 with 12 being associated with the worst outcome. | Change from baseline to Days 4, 8, 15, 22, and 29 |
| Manchester |
| United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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