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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
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The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.
This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUR0200 low dose | Experimental | PUR0200 low dose, single dose inhalation |
|
| PUR0200 mid dose | Experimental | PUR0200 mid dose, single dose inhalation |
|
| PUR0200 high dose | Experimental | PUR0200 high dose, single dose inhalation |
|
| Placebo | Placebo Comparator | PUR0200 matched placebo, single dose, inhalation |
|
| Active Comparator | Active Comparator | Active Comparator, single dose, inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUR0200 | Drug | Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of PUR0200 | 0 to 24 hours | |
| Time to reach peak plasma (Tmax) concentration of PUR0200 | 0 to 24 hours | |
| Area under the plasma concentration versus time (AUC) of PUR0200 | 0 to 24 hours | |
| Trough forced expiratory volume in 1 second (FEV1) | 24 hours | |
| Trough FEV1 difference from baseline | 24 hours | |
| Number of participants with adverse events | adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated | up to 14 days post-dose |
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Key Inclusion Criteria:
A clinical diagnosis of moderate to severe COPD according to the following criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hava, Ph.D. | Pulmatrix Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom | |||
| Quotient Clinical |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| PUR0200 Placebo | Drug | Randomized, single dose of inhaled placebo matched to PUR0200 |
|
| Active comparator | Drug | Randomized single dose of inhaled active comparator product |
|
| Nottingham |
| NG11 6JS |
| United Kingdom |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |