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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
inhaled PUR118, BID
Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)
Hanover, Germany
Change from baseline in sputum cell counts and inflammatory markers
Time frame: 6 hours post-initiation of ozone challenge
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 pulmonary function
Time frame: all post-dose timepoints up to 24 hours post-initiation of ozone challenge
Changes in clinical signs and symptoms from physical examination at baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Changes in clinical safety laboratory tests from baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Changes in vital signs from baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Changes in ECG from baseline
Time frame: Subjects will be followed for an expected average of 12 weeks
Number of subjects with adverse events
Time frame: Subjects will be followed for an expected average of 12 weeks
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