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PUR0200

Phase 1

Healthy | Small molecule | Other |Pulmatrix, Inc.|Last Updated: Nov 11, 2016

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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02671825A PK Study to Evaluate PUR0200 and a Reference Product in Healthy SubjectsPHASE1 COMPLETED 42 — — Jan 1, 2016Mar 1, 2016Nov 11, 20161 Bulgaria
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Study Endpoints
Primary Endpoints
To assess PK parameter area under the plasma concentration versus time curve (AUC) of 5 formulations of PUR0200 compared to Reference Product
8 hours
To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product
8 hours
Secondary Endpoints
Number of subjects with treatment-related adverse events
8 weeks
Comparison of PK parameters (AUC and Cmax) in subjects dosed with Reference product after ingesting charcoal and without charcoal to assess oral vs inhalation exposure of drug
8 hours
Comparison of PK parameters (AUC and Cmax) in subjects dosed with Reference product in 2 separate periods to assess the intra-subject variability of inhalation exposure to Reference product
8 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PUR0217aEXPERIMENTALPUR0200 formulation 1
PUR0228aEXPERIMENTALPUR0200 formulation 2
PUR0228bEXPERIMENTALPUR0200 formulation 3
PUR0228cEXPERIMENTALPUR0200 formulation 4
PUR0230cEXPERIMENTALPUR0200 formulation 5
Reference Product 1ACTIVE_COMPARATORReference Product formulation with active charcoal
Reference Product 2ACTIVE_COMPARATORReference Product without active charcoal
Interventions
NameTypeDescription
PUR0200DRUGPUR0200 dry powder inhalation
Reference ProductDRUGDry Powder Inhalation Reference Product
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subject * Age between 18 and 50 (inclusive) years * Non-smokers or ex-smokers (stopped at least 6 months ago) * FEV1 ≥80% of the predicted value * Completion of 3 training inhalations Exclusion Criteria: * Pregnant and/or nursing women. Positive pregna...

Countries:Bulgaria
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