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Regular Human Insulin

Phase 1

Healthy | Small molecule | Other |MannKind Corporation|Last Updated: Sep 7, 2012

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01490762Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C InhalerPHASE1 COMPLETED 35 — — Dec 1, 2011Jul 1, 2012Sep 7, 20121 United States
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Study Endpoints
Primary Endpoints
area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing
crossover 4 times over the course of up to 5 weeks
Secondary Endpoints
Area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) compared to that of subcutaneous regular human insulin (RHI)
crossover 5 times over the course of up to 6 weeks
Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI
crossover 5 times over the course of up to 6 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
crossover 5 times for up to 6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Regular Human InsulinACTIVE_COMPARATORSubcutaneous injection
TI and Regular Human InsulinEXPERIMENTALAll subjects have 4 clamp procedures with 10, 30, 60,80 units of TI and 1 clamp with 15 IU Regular Human Insulin
Interventions
NameTypeDescription
Technosphere Insulin Inhalation Powder using the Gen2C inhalerDRUGInhalation Powder
Regular Human InsulinDRUGSubcutaneous injection
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * Good venous access for blood draws * No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negati...

Countries:United States
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