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RECRUITING
NCT07759934
PHASE2

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

Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of ASK0912 for Injection Versus Polymyxin B for Injection in Adult Patients With Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-25

Completion Date

2027-12-25

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

ASK0912 for Injection

ASK0912 for injection administered at a dose of 0.75 mg/kg every 12 hours

DRUG

ASK0912 for Injection

ASK0912 for injection administered at a dose of 0.5 mg/kg every 8 hours

DRUG

Polymyxin B Sulfate for Injection

Polymyxin B Sulfate for Injection:Loading dose of 2.0-2.5 mg/kg; maintaining dose 1.25-1.5 mg/kg after 12 hours

Locations (1)

Jiangsu AOSAIKANG Pharm

Nanjing, Jiangsu, China