Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler

Exclusion Criteria

• •Blood donation of 500 mL within the previous 56 days
• •Fasting blood sugar \>130 mg/dL
• •History of coronary artery disease, peripheral vascular disease, or congestive heart failure
• •Allergy to study drug, food, or other study material (eg, peanuts, soy products)
• •Clinically significant active or chronic illness
• •History of asthma, COPD, or any other clinically relevant chronic lung disease
• •Respiratory tract infection within 4 weeks before screening
• •Donation of blood within 3 months before screening
• •History of drug or alcohol abuse
• •Positive urine drug screen
• •Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
• •Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study
• •Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism (except metformin
• •History of malignancy within the 5 years before screening (other than basal cell carcinoma)
• •History of human immunodeficiency virus (HIV) infection or hepatitis B or C
• •Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
• •Any subject who at Visit 2 has a blood glucose value = 150 mg/dL 2 hours after the meal, should be discussed with the MKC medical monitor and may be removed as potentially having impaired glucose tolerance
• •Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder
• •Women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile