Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUR118 low dose | Experimental |
| |
| PUR118 mid dose | Experimental |
| |
| PUR118 high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUR118 | Drug | inhaled PUR118, BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sputum cell counts and inflammatory markers | 6 hours post-initiation of ozone challenge | |
| Change from baseline in white blood cell and inflammatory biomarker counts in blood | 7 and 24 hours post-initiation of ozone challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pulmonary function | all post-dose timepoints up to 24 hours post-initiation of ozone challenge | |
| Changes in clinical signs and symptoms from physical examination at baseline | Subjects will be followed for an expected average of 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Hanrahan, MD | Pulmatrix Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM) | Hanover | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26265479 | Derived | Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial. BMC Pharmacol Toxicol. 2015 Aug 12;16:21. doi: 10.1186/s40360-015-0021-1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007249 | Inflammation |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |