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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
I.V., multiple-dose (Day 1 and Day 22)
I.V., multiple-dose (Day 1 and Day 22)
I.V., single-dose (Day 1)
I.V., single-dose (Day 1)
Queen Anne Street Medical Centre
London, United Kingdom
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom
Maximum percentage fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after administration of allergen inhalation challenge (Part 1).
Time frame: 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).
Time frame: Change from baseline to Day 22
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).
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge
Change from baseline in pre-challenge FEV1 (Part 1).
Time frame: Change from baseline to Day 29
Change from baseline in percentage of neutrophils (Part 2).
Time frame: 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).
Time frame: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2).
Time frame: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2).
Time frame: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2).
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to Days 4, 8, 15, 22, and 29
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