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
The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDT-637 | Experimental | Active formulation |
|
| Placebo | Placebo Comparator | Matched Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDT-637 | Drug | Inhaled doses of MDT-637 over a 10 day period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of 3 escalating doses of MDT-637 dry powder inhalation in healthy volunteers | Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events. | Up to 48 days (including up to 28 days of screening period) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics for MDT-637 dry powder inhalation | Plasma Samples will be measured to determine MDT-637 pharmacokinetics | Multiple plasma samples collected during the dosing period, upto 24 hr post last dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Cypress | California | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C423511 | VP-14637 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MDT-637 |
| Drug |
Inhaled doses of MDT-637 over a 10 day period |
|
| D014777 | Virus Diseases |
| D007239 | Infections |