Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges

A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.

Inclusion Criteria:

• Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
• No smoking in the past 6 months (including cigarettes, cigars, and pipes)
• Urine cotinine testing < 100 ng/mL
• Body mass index < 32 kg/m2
• Completion of informed consent form

Exclusion Criteria:

• FBG > 100 mg/dL
• Clinically significant active or chronic illness
• History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
• Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
• Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea