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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
WCCT
Cypress, California, United States
Area under the insulin curve (AUC)
Area under the insulin curve (AUC)
Time frame: 10 hours
Area under the glucose infusion rate curve (GIR)
Area under the glucose infusion rate curve (GIR)
Time frame: 10 hours
Area under the insulin curve following inhalation of salbutamol
Area under the insulin curve following inhalation of salbutamol in subjects with asthma
Time frame: 10 hours
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