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

Ventilator-associated Bacterial Pneumonia Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06087536
• Other study ID #: OMN6-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Omnix Medical Ltd
• Contact: Bella Shusterman
• Phone: +972 2 5320871
• Email: bella[@]omnixmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. A signed informed consent form.

2. Male or female patients 18 years or older

3. A diagnosis of either a HABP or a VABP

4. ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens

5. 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.

6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

Exclusion Criteria:

1. Moderate to severe reduction of renal function

2. Liver dysfunction

3. Evidence of septic shock

4. Acute respiratory distress syndrome.

5. Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).

6. History of any known hypersensitivity to colistin or to carbapenems

7. 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

Related Conditions & MeSH terms

• Hospital-acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Ventilator-associated Bacterial Pneumonia

Intervention

Drug:
• OMN6
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
• Placebo
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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Omnix Medical Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To asses the Cmax of OMN6 in patient population	Maximum Observed Plasma Concentration	1 day
Primary	To assess the Tmax of OMN6 in patient population	Time to Cmax	1 day
Primary	To assess the AUC of OMN6 in patient population	Area Under the Plasma Concentration-Time Curve	1 day
Primary	To assess the t1/2 of OMN6 in patient population	Time to Half-life	1 day

External Links

•   In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii
•   OMN6 a novel bioengineered peptide for the treatment of multidrug resistant Gram negative bacteria