Recent Updates
Recently added Catalysts

PUR118

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Pulmatrix, Inc.|Last Updated: Sep 7, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01333904Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118PHASE1 COMPLETED 90 — — Feb 1, 2011Jun 1, 2012Sep 7, 20121 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events
2 weeks
Secondary Endpoints
Assessment of biomarkers of inflammation and COPD in induced sputum in mild COPD subjects after short multi-dosing with PUR118 compared to baseline
2 days
Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline
single dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PUR118EXPERIMENTAL -
Interventions
NameTypeDescription
PUR118DRUGinhaled
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Main Inclusion Criteria Parts I \& II * Healthy males or non pregnant, non lactating healthy females; * Age 18-65 years of age; * Must be willing and able to communicate in English and participate in the whole study; * Must provide written informed consent. Main Exclusion Criteria Parts I \& II *...

Countries:United Kingdom
Unlock Eligibility Criteria