NCT06087536

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
10mo left

Started Mar 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

July 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

July 25, 2023

Last Update Submit

March 8, 2026

Conditions

Hospital-acquired Bacterial PneumoniaVentilator-associated Bacterial Pneumonia

Keywords

HABP VABP ABC Acinetobacter baumannii pneumonia

Outcome Measures

Primary Outcomes (5)

  • To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin

    Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.

    28 day

  • To asses the Cmax of OMN6 in patient population

    Maximum Observed Plasma Concentration

    1 day

  • To assess the Tmax of OMN6 in patient population

    Time to Cmax

    1 day

  • To assess the AUC of OMN6 in patient population

    Area Under the Plasma Concentration-Time Curve

    1 day

  • To assess the t1/2 of OMN6 in patient population

    Time to Half-life

    1 day

Study Arms (2)

OMN6 treatment

EXPERIMENTAL

OMN6 on top of Meropenem and Colistin

Drug: OMN6

Placebo

PLACEBO COMPARATOR

Placebo on top of Meropenem and Colistin

Drug: Placebo

Interventions

OMN6DRUG

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

OMN6 treatment
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A signed informed consent form.
  • Male or female patients 18 years or older
  • A diagnosis of either a HABP or a VABP
  • ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
  • Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.
  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

You may not qualify if:

  • Moderate to severe reduction of renal function
  • Liver dysfunction
  • Evidence of septic shock
  • Acute respiratory distress syndrome.
  • Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
  • History of any known hypersensitivity to colistin or to carbapenems
  • Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Omnix Medical Research Site

Be’er Ya‘aqov, Israel

RECRUITING

Omnix Medical Research Site

Holon, Israel

RECRUITING

Omnix Medical Research Site

Petah Tikva, Israel

RECRUITING

Omnix Medical Research Site

Ramat Gan, Israel

RECRUITING

Omnix Medical Research Site

Rishon LeZiyyon, Israel

RECRUITING

Related Links

Central Study Contacts

Bella Shusterman

CONTACT

+972 2 5320871bella@omnixmedical.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

October 17, 2023

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(5)