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The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: MDT-637 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDT-637 | Drug | Inhaled doses of MDT-637 over a 24 hour period at 3 visits |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma. | Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events. | Up to 61 days (including up to 42 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, upto 24 hr post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Purvee Shah, MD | West Coast Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Costa Mesa | California | 92626 | United States |
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| Label | URL |
|---|---|
| Development Program Information | View source |
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| Placebo |
| Drug |
|
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C423511 | VP-14637 |
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