2 results
Approved WMOCompleted
To assess the safety and tolerability of escalating single IV doses of NI-0801.To determine the pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.
Approved WMOCompleted
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…