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This is a single-center, open-label, single-dose study. The primary objective is to determine Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess tolerability and safety of a single dose of ME1100 inhalation solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME1100 | Experimental | ME1100 inhalation solution 0.6 mL for 90 mg, Single Dose ME1100 inhalation solution 3.0 mL for 450 mg, Single Dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME1100 inhalation solution | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile in ELF | Each subject will undergo fiber-optic bronchoscopy for the collection of bronchoalveolar lavage fluid at one of the following time points:5 minutes after END of dosing, 0.5, 1, 3, 6 and 12 hrs post START of dosing. | 0-12 hours after START of Dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of ME1100 | 2, 5, 10 minutes after END of dosing, 0.5, 1, 3, 6 and 12 hrs post START of dosing | |
| Number of participants with abnormal safety laboratory measurements | from Baseline to Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitsuharu Egawa | Meiji Seika Pharma Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | United States |
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| ID | Term |
|---|---|
| C031986 | arbekacin |
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