Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PUR0200 · 2 trials · 2 indications
adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated
| Arm | Type | Description |
|---|---|---|
| PUR0217a | EXPERIMENTAL | PUR0200 formulation 1 |
| PUR0228a | EXPERIMENTAL | PUR0200 formulation 2 |
| PUR0228b | EXPERIMENTAL | PUR0200 formulation 3 |
| PUR0228c | EXPERIMENTAL | PUR0200 formulation 4 |
| PUR0230c | EXPERIMENTAL | PUR0200 formulation 5 |
| Reference Product 1 | ACTIVE_COMPARATOR | Reference Product formulation with active charcoal |
| Reference Product 2 | ACTIVE_COMPARATOR | Reference Product without active charcoal |
| 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 |
|---|---|---|
| PUR0200 | DRUG | PUR0200 dry powder inhalation |
| Reference Product | DRUG | Dry Powder Inhalation Reference Product |
| PUR0200 Placebo | DRUG | Randomized, single dose of inhaled placebo matched to PUR0200 |
| Active comparator | DRUG | Randomized single dose of inhaled active comparator product |
Inclusion Criteria: * Healthy male or female subject * Age between 18 and 50 (inclusive) years * Non-smokers or ex-smokers (stopped at least 6 months ago) * FEV1 ≥80% of the predicted value * Completion of 3 training inhalations Exclusion Criteria: * Pregnant and/or nursing women. Positive pregna...
PUR0200 is an investigational small molecule being developed for respiratory conditions. It has been studied in healthy subjects and in patients with Chronic Obstructive Pulmonary Disease (COPD). It is not approved and remains in clinical development.
PUR0200 is being developed by Pulmatrix, Inc., a biopharmaceutical company traded on NASDAQ under the ticker PULM. The company has conducted Phase 1 clinical trials of PUR0200 in both healthy volunteers and COPD patients.
PUR0200 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in COPD patients and one in healthy subjects. The drug is investigational and has not received regulatory approval.
PUR0200 has been studied in two completed Phase 1 trials. NCT01921712 evaluated safety, pharmacokinetics, and pharmacodynamics in 38 COPD patients in the United Kingdom. NCT02671825 was a pharmacokinetic study comparing PUR0200 to a reference product in 42 healthy subjects in Bulgaria.
PUR0200 is being studied as a potential alternative to a reference product. In clinical trial NCT02671825, PUR0200 was compared directly with a reference product in healthy subjects to evaluate pharmacokinetic profiles. The reference product is not named in the trial record.