The CIC conducts proof of mechanism studies in subjects with asthma to evaluate the effects of investigational therapy using human models of disease, such as allergen-induced late asthmatic response, allergen PC15, and airway inflammation.

Key features of these studies include:

1. placebo-controlled, parallel-group or crossover design
2. sample size requirement of 20-40 subjects
3. bronchoprovocation with allergen, methacholine and/or mannitol
4. PK/PD and exploratory outcomes
5. well-characterized subjects with mild allergic asthma
6. multiple dosing cohorts, multiple challenges
7. standardized SOPs