Clinical Trial

ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

Recruiting Phase 2
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Summary
This is a randomized, active-controlled, multicenter phase II clinical trial. The study aims to evaluate the efficacy, safety and tolerability of two different dosing regimens of ASK0912 for Injection compared with Polymyxin B Sulfate for Injection in adult patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by multidrug-resistant or carbapenem-resistant Gram-negative bacilli. Eligible subjects will be randomly assigned to one of three treatment groups: ASK0912 Regimen 1, ASK0912 Regimen 2, or Polymyxin B Sulfate active comparator group. Subjects will receive assigned intravenous study treatment for 7 to 14 days. The primary efficacy endpoints include clinical cure rate at the Test of Cure (TOC) visit and Day 28 all-cause mortality in the modified intent-to-treat (MITT) population. Safety assessments will be conducted throughout the study to monitor adverse events, laboratory parameters and other safety indicators.
Trial Details
NCT Number NCT07759934
Lead Sponsor Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Conditions Ventilator-associated Bacterial Pneumonia (VABP), Hospital-acquired Bacterial Pneumonia (HABP)
Enrollment 60 participants
Start Date 2026-03-25
Primary Completion 2027-10-20 (estimated)
Study Completion 2027-12-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-12