Pharmacokinetic Study in Healthy Volunteers

Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler

Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

Inclusion Criteria:

• Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
• Body mass index (BMI) < 32 kg/m2
• FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria:

• Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
• History of coronary artery disease, peripheral vascular disease, or congestive heart failure
• Blood donation within the previous 3 months