RecruitingPhase 2NCT06087536

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

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


Sponsor

Omnix Medical Ltd

Enrollment

54 participants

Start Date

May 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called OMN6 and a drug called Placebo for people with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOMN6

Cohort 1: 50 mg x 3/day Cohort 2: 100 mg x 3/day Cohort 3: 150 mg x 3/day 3 x 3-hour IV infusions for 1 Day of treatment concomitant with background antimicrobial treatment with meropenem plus colistin for 7 to 14 days

DRUGPlacebo

3 x 3-hour IV infusions for 1 Day of treatment concomitant with background antimicrobial treatment with meropenem plus colistin for 7 to 14 days


Locations(6)

Omnix Medical Research Site

Ashdod, Israel

Omnix Medical Research Site

Be’er Ya‘aqov, Israel

Omnix Medical Research Site

Holon, Israel

Omnix Medical Research Site

Petah Tikva, Israel

Omnix Medical Research Site

Ramat Gan, Israel

Omnix Medical Research Site

Rishon LeZiyyon, Israel

View Full Details on ClinicalTrials.gov

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NCT06087536


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