A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL)

Phase 1 Completed 13 enrolled Mannkind Corporation

RandomizedSingle-groupOpen-labelTreatment

Summary

Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is aspirated out to remove any remaining TI. It's performed twice at specific time points in 12 healthy volunteers. BAL fluid will be analyzed for insulin and FDKP.

Timeline

Start: 2008-07
Primary completion: 2008-10
Completion: 2008-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin	Protein / enzyme biologic	60 iu	Inhaled

Indications

No indication recorded.