This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayceâ„¢ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
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Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Timeframe: Day 1 through 56.
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Timeframe: Day 1 through 56.
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Timeframe: Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28
Treatment-emergent PFT Abnormalities up to the End of Study
Timeframe: Day 1, Day 14 and Day 28
Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
Timeframe: Screening to Day 56
Serious Adverse Events up to 28 Days After Study Medication Discontinuation
Timeframe: Screening to Day 56