The objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Guys Drug Research Unit (GDRU), Quintiles Ltd
London, United Kingdom
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.
Time frame: Day 6
Subjected-reported symptom scores assessed both individually and as a composite score evaluating severity overall and at the time of peak symptom score
Time frame: Day 6 of study
Quantitative viral shedding from nasal viral inoculation until day 6
Time frame: Day 0 to day 6
Change in bioaerosol output with treatment and after viral inoculation
Time frame: Day -2 to day 6
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