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TI- A

Phase 1

Undisclosed | Small molecule | Other |MannKind Corporation|Trials Updated: Oct 2, 2014

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

TI- A clinical trials

TI- A · 1 trial · 1 indication

Phase 1 1
NCT01982604Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different SuppliersHealthy Volunteers
COMPLETED38 Analytics
PHASE1COMPLETED
Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes
5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
Cmax (maximum serum insulin concentration)
5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240

Secondary Endpoints

GIR (area-under-the-serum Glucose Infusion Rate)
0 to 360
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence (Group) 1EXPERIMENTALSubjects randomized to Sequence 1 will receive TI in the following sequence: TI-Inhalation Powder A TI-Inhalation Powder B \*30 units (10 units + 20 units)
Sequence (Group) 2EXPERIMENTALSubjects randomized to Sequence 2 will receive TI in the following sequence: TI-Inhalation Powder B TI-Inhalation Powder A \*30 units (10 units + 20 units)

Interventions

NameTypeDescription
TI-Inhalation Powder ADRUGInhaled Insulin
TI-Inhalation Powder BDRUGInhaled Insulin
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * HNVs with a screening blood pressure less than 140/90 mm Hg * Subjects who have hypertension controlled with up to 1 medica...

Countries:United States
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Frequently asked questions about TI- A

What is TI-A?

TI-A is an investigational inhaled insulin product developed by MannKind Corporation. It is also known as TI-Inhalation Powder A and is based on the company's Technosphere insulin delivery technology. It is a small molecule therapeutic candidate that has been studied in a Phase 1 clinical trial involving healthy adult volunteers.

What is TI-A used for?

TI-A is being developed as an inhaled insulin therapy. The specific disease indication for TI-A has not been publicly disclosed by the developer. Its only recorded clinical study enrolled healthy volunteers rather than patients with a defined condition, so the target indication remains undisclosed at this stage of development.

Who makes TI-A?

TI-A is developed by MannKind Corporation, which trades on the Nasdaq under the ticker MNKD. MannKind is the sponsor of the clinical program for TI-A and its associated inhalation powder formulation. The drug is based on the company's Technosphere insulin delivery platform.

What phase is TI-A in?

TI-A is in Phase 1 clinical development. It is an investigational product and is not approved by the FDA. MannKind Corporation has completed one Phase 1 trial of TI-A, and no active trials of the drug are currently listed. Further development status has not been announced.

What clinical trials is TI-A in?

TI-A has been studied in one completed Phase 1 trial, NCT01982604, titled Comparison of 30 Units of TI (Technosphere Insulin) Prepared With Insulin From Two Different Suppliers. The trial enrolled 38 healthy adult volunteers in the United States, was randomized and controlled, and did not use blinding. No active trials are listed.

Is TI-A the same as TI-Inhalation Powder A?

Yes. TI-A and TI-Inhalation Powder A refer to the same MannKind Corporation investigational product. TI-A is the short name, while TI-Inhalation Powder A describes the inhaled powder formulation. Both names point to the same Phase 1 small molecule program studied under NCT01982604.