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| Name | Class |
|---|---|
| Retroscreen Virology Ltd. | INDUSTRY |
| Quintiles, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUR003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUR003 | Drug | Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjected-reported symptom scores assessed both individually and as a composite score evaluating severity overall and at the time of peak symptom score | Day 6 of study | |
| Quantitative viral shedding from nasal viral inoculation until day 6 | Day 0 to day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Hanrahan, MD | Pulmatrix Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys Drug Research Unit (GDRU), Quintiles Ltd | London | SE1 1YR | United Kingdom |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000597599 | PUR003 |
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| Placebo | Drug |
|
| Change in bioaerosol output with treatment and after viral inoculation | Day -2 to day 6 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |