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Technosphere Insulin 10U + 20U

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01902121Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 CartridgePHASE1 COMPLETED 40Aug 1, 2013Aug 1, 2014Dec 12, 20141 United States
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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 — 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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