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Also known as TI Inhalation Powder, Technosphere Insulin Inhalation Powder
TI · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TI Inhalation Powder | EXPERIMENTAL | TI Inhalation Powder, single dose, 60 units |
| Name | Type | Description |
|---|---|---|
| TI Inhalation Powder | DRUG | 1 60-U dose of TI Inhalation Powder before the bronchoscopy. Cohort 1 will undergo bronchoscopies at 30 minutes and again at 6 hours after the 60-U dose inhalation of TI Inhalation Powder. Cohort 2 bronchoscopies will occur at 4 hours and again at 8 hours after TI Inhalation Powder. The need to run and the timepoints for bronchoscopies for Cohort 3 will be determined based on the results from Cohort 1 and 2. All subjects will undergo 2 bronchoscopies at Visit 2. |
Inclusion Criteria: * Nonsmokers for greater than or equal to 12 months * Normal chest x-ray (CXR) at Screening/Visit 1 * Prebronchodilator FEV1 greater than or equal to 80% Third National Health and Nutrition Examination Survey (NHANES) III Predicted * Prebronchodilator FEV1/FVC greater than or eq...
TI is an inhaled insulin powder developed by MannKind Corporation under the ticker MNKD. It is also known as TI Inhalation Powder. The formulation is a small molecule therapeutic delivered to the lungs, and it has been studied in a Phase 1 clinical trial involving healthy adult volunteers.
TI is developed by MannKind Corporation, which trades under the ticker MNKD. The company sponsored the clinical work evaluating the inhaled powder, including a Phase 1 trial conducted in the United States. MannKind is the sole developer named for this asset.
TI is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because the program remains at the Phase 1 stage, TI is investigational and has not been approved by the FDA for any indication.
TI has been studied in one completed Phase 1 trial, NCT00757367. That trial enrolled 13 healthy adult volunteers in the United States and examined how long insulin and FDKP, the molecule that forms Technosphere particles, remain in the lungs after inhalation of TI powder using bronchoalveolar lavage.
Yes. TI and TI Inhalation Powder refer to the same MannKind Corporation product. TI Inhalation Powder is the fuller name used in trial documentation, while TI is the shorter form. Both describe the inhaled insulin formulation delivered as a powder to the lungs.
NCT00757367 was a completed Phase 1 trial of TI Inhalation Powder that enrolled 13 participants. It was randomized but not double blinded and used an uncontrolled design. Participants were healthy volunteers aged 18 years and older, and the study took place in the United States.