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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
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
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
Omnix Medical Research Site
Be’er Ya‘aqov, Israel
RECRUITINGOmnix Medical Research Site
Holon, Israel
RECRUITINGOmnix Medical Research Site
Petah Tikva, Israel
RECRUITINGTo 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.
Time frame: 28 day
To asses the Cmax of OMN6 in patient population
Maximum Observed Plasma Concentration
Time frame: 1 day
To assess the Tmax of OMN6 in patient population
Time to Cmax
Time frame: 1 day
To assess the AUC of OMN6 in patient population
Area Under the Plasma Concentration-Time Curve
Time frame: 1 day
To assess the t1/2 of OMN6 in patient population
Time to Half-life
Time frame: 1 day
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Omnix Medical Research Site
Rishon LeZiyyon, Israel
RECRUITING