A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma

Exclusion Criteria

• •1. Past or present disease which, as judged by the investigator, may affect the outcome of this study.
• •2. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the screening period.
• •3. Symptomatic allergic rhinitis. Those subjects with a history of allergic rhinitis may participate if asymptomatic at screening (and continue to be so at baseline on Day 1 prior to dosing) and if, in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study.
• •4. History of life-threatening asthma.
• •5. Abnormal chest X-ray.
• •6. Use of oral, injectable, or dermal steroids within 3 months and/or inhaled steroids within 1 month of screening.
• •7. Use of cromoglycate, nedocromil, leukotriene receptor antagonists (zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase (zileuton) within 4 weeks of screening.
• •8. Use of immunosuppressives, anticoagulants (warfarin or heparin), or any medications that may interact with pharmacodynamic (PD) effects of AXP1275 within 4 weeks of screening.
• •9. Use of theophylline-containing agents (any type) and long-acting β2-agonists (salmeterol, formoterol) within 4 weeks of screening.
• •10. Positive screen for drug(s) of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, or benzodiazepines) or cotinine.
• •11. Positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) 1/2.
• •12. Has participated in a clinical trial and has received an investigational product within 30 days prior to screening, or 5 elimination half lives of the investigational product, whichever is longer.
• •13. Has had significant blood loss (\>500 mL) or donation of blood within 2 months prior to screening visit 1.
• •14. History of being unable to tolerate or complete methacholine or allergen challenge tests.
• •15. Subject is undergoing allergen desensitization therapy.
• •16. History of immunotherapy in the 3 years prior to screening or concurrently undergoing immunotherapy treatment.
• •17. Professional or ancillary personnel involved in the study.
• •18. Is not, in the opinion of the investigator, suitable for entry into the study.