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PUR003

Phase 1

Healthy | Small molecule | Other |Pulmatrix, Inc.|Last Updated: Sep 19, 2017

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00947687Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult SubjectsPHASE1 COMPLETED 24 — — Jul 1, 2009Oct 1, 2009Sep 19, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
Day 6
Secondary Endpoints
Subjected-reported symptom scores assessed both individually and as a composite score evaluating severity overall and at the time of peak symptom score
Day 6 of study
Quantitative viral shedding from nasal viral inoculation until day 6
Day 0 to day 6
Change in bioaerosol output with treatment and after viral inoculation
Day -2 to day 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PUR003EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PUR003DRUGTwice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female subjects aged 18 to 45 years. * In general good health determined by a screening evaluation ≤120 days prior to double-blind IMP administration and on the day of admittance to quarantine. * Seronegative (NDA) for challenge virus. * Have not been vaccinated for i...

Countries:United Kingdom
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