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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
15 subjects in a three-way crossover (three different doses of TI Inhalation Powder \[one 20 U, two 20 U and one 40 U cartridges)
16 subjects in a four-way crossover (four different doses of TI Inhalation Powder \[one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)\])
Celerion
Neptune City, New Jersey, United States
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
Time frame: 0-120 minutes
Safety will be assessed by adverse events
Time frame: 32 days
Safety will be assessed by Spirometry (FEV1)
Time frame: 32 Days
Safety will be assessed by vital sign measurements
Time frame: 32 Days
Safety will be assessed by physical examination findings.
Time frame: 32 Days
Safety will be assessed by clinical laboratory test results.
Time frame: 32 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.