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PUR118 · 3 trials · 3 indications
Changes in clinical signs and symptoms from physical examination and chest examination, changes in clinical safety laboratory tests, vital signs, spirometry, lung clearance index, 24-hour sputum weight and volume, oxygen saturation, ECG, telemetry, and adverse events.
| Arm | Type | Description |
|---|---|---|
| PUR118 low dose | EXPERIMENTAL | - |
| PUR118 mid dose | EXPERIMENTAL | - |
| PUR118 high dose | EXPERIMENTAL | - |
| PUR118 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PUR118 | DRUG | inhaled PUR118, BID |
Inclusion Criteria: * Healthy males or non pregnant, non lactating healthy females age 18-50 years; * Must be able to produce acceptable sputum sample by induction; * Must respond to ozone inhalation with a \> 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (...
PUR118 is an investigational inhaled small molecule being studied for Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis. It has been evaluated in Phase 1 clinical trials in both healthy volunteers and subjects with these respiratory conditions. It is not approved for any indication.
PUR118 is being developed by Pulmatrix, Inc., a biopharmaceutical company that trades under the ticker symbol PULM. Pulmatrix sponsored the Phase 1 clinical trials evaluating PUR118 in COPD and Cystic Fibrosis.
PUR118 is in Phase 1 clinical development. Two completed Phase 1 trials have evaluated the drug, and no later-phase trials have been initiated. PUR118 is investigational and has not been approved by the FDA for any indication.
PUR118 has been studied in completed Phase 1 trials including NCT01690949, which evaluated the effect of PUR118 on ozone-induced airway inflammation in healthy volunteers, NCT01543191, a safety and tolerability study in subjects with Cystic Fibrosis, and NCT01333904, a safety, tolerability, and pharmacodynamic effect study.
Across the completed Phase 1 trials, 114 participants have been enrolled. NCT01690949 enrolled 24 healthy volunteers, NCT01543191 enrolled 10 subjects with Cystic Fibrosis, and NCT01333904 enrolled 90 participants. The trials were conducted in Germany and the United Kingdom.