The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Amikacin administered via the Pari LC STAR™ nebulizer.
Nebulized saline.
Number of Participants who Experience a Treatment Emergent Adverse Event (TEAE)
Safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
Time frame: Up to Day 28
Area Under the Concentration-time Curve (AUC) of SLIT™ Amikacin in Serum
Time frame: Pre-dose and at multiple time points post-dose up to Day 3
Percent Dose of SLIT™ Amikacin in Urine
Time frame: At multiple time points post-dose up to Day 3
AUC of SLIT™ Amikacin in Sputum
Time frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 14, and 28
Change From Baseline in Sputum Density of Pseudomonas Aeruginosa
Time frame: Baseline up to Day 28
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