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TI

Phase 1

Healthy Subjects | Small molecule | Other |MannKind Corporation|Last Updated: Dec 17, 2013

Success Probability

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

TI · 1 trial · 1 indication

Phase 1 1
NCT00757367A 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)Healthy Subjects
COMPLETED13 Analytics
PHASE1COMPLETED
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)
Healthy Subjects
NCT0075736713
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Study Endpoints

Primary Endpoints

Estimation of the amount of insulin in the lungs and amount of FDKP by analyzing BAL fluid, obtained by a flexible fiber optic bronchoscope at various time points after admin of TI Inhalation Powder.
2 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TI Inhalation PowderEXPERIMENTALTI Inhalation Powder, single dose, 60 units

Interventions

NameTypeDescription
TI Inhalation PowderDRUG1 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.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about TI

What is TI?

TI is an investigational small molecule being developed by MannKind Corporation for use in healthy subjects. It is a form of Technosphere Insulin, an inhaled insulin powder. The drug is currently in Phase 1 clinical development.

What is TI used for?

TI is being studied for use in healthy subjects. It is an inhaled insulin formulation designed to deliver insulin through the lungs. The current clinical trial focuses on determining how long insulin and FDKP, the molecule that forms Technosphere particles, stay in the lungs after inhalation.

Who makes TI?

TI is being developed by MannKind Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the drug's behavior in the lungs of healthy individuals.

What phase is TI in?

TI is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results expected to inform further development.

What clinical trials is TI in?

TI has one completed Phase 1 clinical trial, identified as NCT00757367. The trial enrolled 13 healthy subjects in the United States and used bronchoalveolar lavage to measure how long insulin and FDKP remain in the lungs after inhalation of Technosphere Insulin powder.

Is TI the same as Technosphere Insulin?

Yes, TI is a form of Technosphere Insulin. The drug name TI refers to the inhaled insulin powder that uses Technosphere technology, which involves FDKP molecules forming particles for drug delivery. The clinical trial title explicitly refers to Technosphere Insulin (TI) powder.