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This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME1100 | Experimental | ME1100 inhalation solution (arbekacin for oral inhalation at 150 mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose |
|
| Placebo | Placebo Comparator | ME1100 placebo inhalation solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME1100 inhalation solution | Drug | ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | from Baseline to Day 8-10 | |
| Number of participants with abnormal physical examinations | from Baseline to Day 8-10 | |
| Number of participants with abnormal 12-lead electrocardiograms | from Baseline to Day 8-10 | |
| Number of participants with abnormal vital signs | from Baseline to Day 8-10 | |
| Number of participants with abnormal safety laboratory measurements | from Baseline to Day 8-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of ME1100 | 5, 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post START of dosing | |
| Urinary elimination of ME1100 | 0-6, 6-12, 12-24, 24-48 and 48-72 hours after single dosing |
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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 |
|---|---|---|---|---|---|---|
| WCCT Global, LLC | Cypress | California | United States |
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| ID | Term |
|---|---|
| C031986 | arbekacin |
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| ME1100 placebo inhalation solution | Drug | Vehicle placebo |
|