Recent Updates
Recently added Catalysts

TI- A

Phase 1

Healthy Volunteers | Small molecule | Other |MannKind Corporation|Last Updated: Oct 2, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

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 Volunteers
NCT0198260438
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about TI- A

What is TI-A used for?

TI-A is an investigational small molecule being studied in healthy volunteers. It is a formulation of Technosphere Insulin, and the completed Phase 1 trial evaluated its use in healthy adult participants. TI-A is not approved for any indication and remains in clinical development.

Who makes TI-A?

TI-A is being developed by MannKind Corporation, a biopharmaceutical company traded on NASDAQ under the ticker MNKD. The company conducted a Phase 1 clinical trial of TI-A in the United States.

What phase is TI-A in?

TI-A is in Phase 1 clinical development. The only trial listed for TI-A is a completed Phase 1 study. As an investigational drug, TI-A has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is TI-A in?

TI-A has one completed clinical trial, registered as NCT01982604. The study, titled "Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers," enrolled 38 healthy volunteers in the United States. The trial was controlled but not double-blinded.

Is TI-A the same as Technosphere Insulin?

TI-A is a formulation of Technosphere Insulin, as indicated by the clinical trial title. The study compared 30 units of TI prepared with insulin from two different suppliers. TI-A is the investigational name used in the trial for this Technosphere Insulin product.