Asthma Respiratory Asthma
Conditions
Interventions
On Days 1 - 13, the dose of SMP-028 will be 80 mg twice a day or placebo. A single morning dose of 80 mg SMP-028 or placebo will be taken on Day 14.
Sponsors
Dainippon Sumitomo Pharma Europe Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female (of non childbearing potential) subjects aged between 18 and 65 years who have documented history of bronchial asthma 2. Demonstration of a positive wheal reaction to at least 1 of 3 allergens (house dust mite, grass pollen, cat hair and dander) on skin prick testing 3. Screening allergen challenge demonstrating that the subject experiences both an early and late asthmatic response. 4. Body mass index (BMI) within the range 19.0 - 32.0 kg/m^2 (inclusive) 5. Sensitivity to AMP with a provocative concentration of AMP
Exclusion criteria
Exclusion criteria: 1. Past or present disease which, as judged by the Investigator, may affect the outcome of this study 2. Subject has known history of uncontrolled hypertension or is hypertensive at the Screening visit 3. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study drug 4. Symptomatic allergic rhinitis 5. History of life-threatening asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean baseline-corrected area under the forced expiratory volume in 1 second (FEV1) reduction curve from 4 to 10 hours after allergen challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early Asthmatic Response: FEV1 2. Exhaled NO 3. AMP PC20 4. Induced sputum cell counts 5. induced sputum inflammatory mediators 6. Adverse events 7. Laboratory safety tests 8. Vital signs 9. Physical examinations 10. 12-lead ECGs (electrocardiograms) 11. Pharmacokinetics of SMP-028 and its metabolites Measured on Day 13/14 as appropriate. In addition, safety is followed up until 10 days +/- 3 days after the last dose on Day 14 of Period 2. | — |
Countries
United Kingdom
Outcome results
None listed