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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin — 28 day
  Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.
• To asses the Cmax of OMN6 in patient population — 1 day
  Maximum Observed Plasma Concentration
• To assess the Tmax of OMN6 in patient population — 1 day
  Time to Cmax
• To assess the AUC of OMN6 in patient population — 1 day
  Area Under the Plasma Concentration-Time Curve
• To assess the t1/2 of OMN6 in patient population — 1 day
  Time to Half-life

Trial sites (15)