NCT01690949CompletedPhase 1
Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pulmatrix Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change from baseline in white blood cell and inflammatory biomarker counts in blood
Study Overview
Brief Summary
This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males or non pregnant, non lactating healthy females age 18-50 years;
- •Must be able to produce acceptable sputum sample by induction;
- •Must respond to ozone inhalation with a > 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
- •Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.
Exclusion Criteria
- •Volunteers receiving chronic medication other than oral contraceptives;
- •Screening forced expiratory volume FEV1 is < 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
- •Volunteers with significant occupational exposure to respiratory irritants or toxins
- •Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
- •Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day;
- •Volunteers with a history of asthma
Arms & Interventions
PUR118 low dose
Experimental
Intervention: PUR118 (Drug)
PUR118 mid dose
Experimental
Intervention: PUR118 (Drug)
PUR118 high dose
Experimental
Intervention: PUR118 (Drug)
Outcomes
Primary Outcomes
Change from baseline in white blood cell and inflammatory biomarker counts in blood
Time Frame: 7 and 24 hours post-initiation of ozone challenge
Change from baseline in sputum cell counts and inflammatory markers
Time Frame: 6 hours post-initiation of ozone challenge
Secondary Outcomes
- Changes in clinical signs and symptoms from physical examination at baseline(Subjects will be followed for an expected average of 12 weeks)
- Changes in clinical safety laboratory tests from baseline(Subjects will be followed for an expected average of 12 weeks)
- Changes in vital signs from baseline(Subjects will be followed for an expected average of 12 weeks)
- Changes in ECG from baseline(Subjects will be followed for an expected average of 12 weeks)
- Number of subjects with adverse events(Subjects will be followed for an expected average of 12 weeks)
- Change from baseline in pulmonary function(all post-dose timepoints up to 24 hours post-initiation of ozone challenge)
Investigators
Study Sites (1)
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