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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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
Vehicle placebo
WCCT Global, LLC
Cypress, California, United States
Number of participants with adverse events
Time frame: from Baseline to Day 8-10
Number of participants with abnormal physical examinations
Time frame: from Baseline to Day 8-10
Number of participants with abnormal 12-lead electrocardiograms
Time frame: from Baseline to Day 8-10
Number of participants with abnormal vital signs
Time frame: from Baseline to Day 8-10
Number of participants with abnormal safety laboratory measurements
Time frame: from Baseline to Day 8-10
Serum Concentration of ME1100
Time frame: 5, 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post START of dosing
Urinary elimination of ME1100
Time frame: 0-6, 6-12, 12-24, 24-48 and 48-72 hours after single dosing
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