A Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Trial to Assess Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex

What this Trial Is About

Researchers are conducting a phase 2a, multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial to study patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). The study aims to identify safe and well-tolerated doses and assess the pharmacokinetics (PK) of the drug OMN6 in these patients. This research evaluates how OMN6 behaves in the body and its safety when added to standard therapy. Participants will be randomly assigned to one of two groups: one receiving OMN6 along with standard antimicrobial treatment using meropenem and colistin, and the other receiving a placebo combined with the same standard treatments. OMN6 is given as three intravenous infusions of either 50 mg, 100 mg, or 150 mg each, administered over three hours, all delivered on a single day. The background treatment with meropenem and colistin continues for 7 to 14 days. The study compares safety and PK profiles between these groups. During the trial, participants will be monitored for safety over 28 days following treatment. Pharmacokinetic measurements like the maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC), and half-life (t1/2) of OMN6 will be assessed within one day of dosing. Safety evaluations include observing adverse events and other clinical parameters. This thorough monitoring will help researchers understand OMN6's safety and behavior in patients with HABP or VABP caused by ABC, with the study expected to continue until March 2027.

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