PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
This will be a randomized, open-label, active-controlled, single dose crossover study with
 either three or four treatment periods. Investigational treatment is with Dance 501 Human
 Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).

 Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic
 obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung
 disease (healthy subjects).
The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be
 compared to subcutaneous injection of insulin lispro.
Inclusion Criteria:

 -  non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6
 months prior to enrollment. BMI <= 35 kg/m2. Fasting blood glucose <= 125 mg/dL.

 Exclusion Criteria:

 -  pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4
 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma
 or COPD within previous 3 months. Clinically significant medical condition. Current
 medications interfering with glucose metabolism.