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PUR003

Phase 1

Asthma | Small molecule | Respiratory |Pulmatrix, Inc.|Trials Updated: Nov 22, 2011

PUR003 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

PUR003 clinical trials

PUR003 · 1 trial · 3 indications

Phase 1 1
NCT00989521Effect of PUR003 on AsthmaAsthma
COMPLETED7 Analytics
PHASE1COMPLETED
Effect of PUR003 on Asthma
AsthmaUnlock trial analytics

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.
after three doses
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placeboPLACEBO_COMPARATORnormal saline for inhalation
PUR003ACTIVE_COMPARATORPUR003 for inhalation

Interventions

NameTypeDescription
PUR003DRUGPUR003 for inhalation
PlaceboDRUGNormal saline for inhalation
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed written informed consent. 2. Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments. 3. Adult male or female subject, 18-60 years of age. 4. Stable, mild asthma not requiring any medical treatment other than s...

Countries:Canada
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Frequently asked questions about PUR003

What is PUR003?

PUR003 is an investigational small molecule developed by Pulmatrix, Inc. for asthma. It has been studied in a single Phase 1 clinical trial that has been completed. PUR003 is not approved for any indication and remains in clinical development.

What is PUR003 used for?

PUR003 is being developed for the treatment of asthma. The only clinical trial of PUR003 enrolled participants with asthma and related lung and bronchial diseases. It is an investigational therapy and has not been approved for commercial use.

Who makes PUR003?

PUR003 is developed by Pulmatrix, Inc., a biopharmaceutical company whose common stock trades under the ticker symbol PULM. Pulmatrix is the sponsor of the clinical program evaluating PUR003 in asthma.

What phase is PUR003 in?

PUR003 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not advanced beyond early-stage testing.

What clinical trials is PUR003 in?

PUR003 has been evaluated in one completed Phase 1 trial, NCT00989521, titled Effect of PUR003 on Asthma. The trial enrolled 7 participants in Canada, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older of all sexes.

Is PUR003 FDA approved?

No, PUR003 is not FDA approved. It is an investigational small molecule that has completed a single Phase 1 clinical trial for asthma. Approval would require successful results in later-stage clinical development, which has not been reported.