Phase 2a Clinical Trial to Evaluate the Safety and Pharmacokinetics of OMN6 with Meropenem and Colistin in Adults with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia Caused by Acinetobacter Baumannii Complex

What this Trial Is About

This clinical trial is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics PK of OMN6 in patients with hospital-acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP caused by the Acinetobacter baumannii complex ABC. The purpose is to identify safe and well-tolerated doses of OMN6 and understand its behavior in the body when added to standard therapies. Participants receive either OMN6 or a placebo alongside background antibiotic treatment with meropenem and colistin. OMN6 is given in three dosing cohorts 50 mg, 100 mg, or 150 mg, each administered as three 3-hour intravenous infusions on a single day, while meropenem plus colistin treatment continues for 7 to 14 days. The comparator group receives matching placebo infusions under the same schedule plus the background antibiotics. Throughout the study, participants are closely monitored for safety and the pharmacokinetics of OMN6, including measures such as maximum concentration, time to maximum concentration, area under the curve, and half-life. Safety assessments focus on the 28 days following the single-day infusion. The trial includes randomized assignment and double-blinding to ensure unbiased evaluation. The total study duration extends until primary completion in March 2027.

A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex