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Technosphere Insulin 10U+ 20U

Phase 1

Healthy Volunteers | Small molecule | Other |MannKind Corporation|Last Updated: Dec 12, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Technosphere Insulin 10U+ 20U · 1 trial · 1 indication

Phase 1 1
NCT01902121Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 CartridgeHealthy Volunteers
COMPLETED40 Analytics
PHASE1COMPLETED
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
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Study Endpoints

Primary Endpoints

Area-under-the-serum insulin concentration versus time curve (AUC0-240min
0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TI 30 units (10 unit + 20 unitEXPERIMENTALTechnosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
TI 30 units (30 unit cartridgeEXPERIMENTALTechnosphere® Insulin 30 units given as one 30 unit cartridge

Interventions

NameTypeDescription
Technosphere® Insulin 10U + 20UDRUGInhaled Insulin
Technosphere® Insulin 30UDRUGInhaled Insulin
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * No smoking in the past 6 months (including cigarettes, cigars, and pipes) * Urine cotinine testing \< 100 ng/mL * Body mass inde...

Countries:United States
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Frequently asked questions about Technosphere Insulin 10U+ 20U

What is Technosphere Insulin 10U+ 20U?

Technosphere Insulin 10U+ 20U is an investigational small molecule being developed by MannKind Corporation (MNKD) for use in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being studied to compare the same dosage of insulin using a combination of cartridges, specifically 30 units as 2 cartridges versus 1 cartridge.

What does Technosphere Insulin 10U+ 20U target?

Technosphere Insulin 10U+ 20U is an insulin product, so it targets insulin receptors in the body to regulate glucose metabolism. As an insulin formulation, it is designed to deliver insulin to help control blood sugar levels. The drug is being studied in healthy volunteers to assess its pharmacokinetics and pharmacodynamics.

Who makes Technosphere Insulin 10U+ 20U?

Technosphere Insulin 10U+ 20U is developed by MannKind Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate this insulin formulation in healthy volunteers.

What phase is Technosphere Insulin 10U+ 20U in?

Technosphere Insulin 10U+ 20U is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial involving healthy volunteers to evaluate its safety and pharmacokinetics.

What clinical trials is Technosphere Insulin 10U+ 20U in?

Technosphere Insulin 10U+ 20U has one completed clinical trial registered under NCT01902121. This Phase 1 study, titled 'Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge,' enrolled 40 healthy volunteers in the United States. The trial was controlled but not double-blinded.

Is Technosphere Insulin 10U+ 20U the same as other insulin products?

Technosphere Insulin 10U+ 20U is a specific formulation of insulin developed by MannKind Corporation. It is designed to deliver insulin via a unique technosphere technology. While it contains insulin, it is distinct from other insulin products due to its delivery mechanism and cartridge configuration being studied in clinical trials.