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

NCT07759934 | Recruiting Phase 2

• 1 other identifier: ASK0912-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP)

Keywords

Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia; Polymyxin B; ASK0912

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Clinical Cure at Test of Cure (TOC) Visit in the Modified Intent to Treat (MITT) Population

  Clinical cure was defined as all pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving clinical cure at TOC visit in the MITT population is presented.

  Up to approximately 28 days

• Percentage of Participants With All-cause Mortality(ACM) Through Day 28 in the Modified Intent to Treat (MITT) Population

  For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.

  Up to approximately 28 days

Secondary Outcomes (5)

• Clinical cure rate

  Up to approximately 14 days

• All-cause mortality

  14 days post-randomization

• Microbiological success rate

  28 days post-randomization

• Composite clinical and microbiological cure rate

  28 days post-randomization

• Early clinical response rate

  Day 3 post-dose

Study Arms (3)

ASK0912 Regimen 1

EXPERIMENTAL

0.75 mg/kg every 12 hours

Drug: ASK0912 for Injection

ASK0912 Regimen 2

EXPERIMENTAL

0.5 mg/kg every 8 hours

Drug: ASK0912 for Injection

Polymyxin B Sulfate for Injection

ACTIVE COMPARATOR

Loading dose: 2.0-2.5 mg/kg; maintenance dose: 1.25-1.5 mg/kg every 12 hours

Drug: Polymyxin B Sulfate for Injection

Interventions

ASK0912 for Injection DRUG

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

ASK0912 Regimen 1

Polymyxin B Sulfate for Injection DRUG

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

Polymyxin B Sulfate for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-75 years on the day of informed consent signature;
• \. Require intravenous antibiotic therapy for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
• \. At least one clinical sign or symptom of HABP/VABP.
• \. At least one laboratory abnormality of HABP/VABP.
• \. Chest imaging at screening demonstrating new or progressive infiltrates consistent with pneumonia.
• \. APACHE II score ≤ 30.
• \. Appropriate lower respiratory tract specimen obtained at screening for Gram stain and bacterial culture.
• \. Subjects receiving HABP/VABP-active antibiotics within 72h pre-enrollment may enroll if ≤24h therapy, or ≥48h with persistent/worsening HABP/VABP signs/symptoms at screening.
• \. Women of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment.
• \. Male subjects must use highly effective contraception throughout the study period.

You may not qualify if:

• \. Subjects with known allergy to polymyxins or carbapenems, regardless of the severity of the reaction; or subjects with a severe hypersensitivity reaction to any other β-lactam agent.
• \. Subjects who have received any investigational product within 3 months prior to enrollment, or subjects who have previously participated in this clinical study.
• \. Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only.
• \. Known or suspected pneumonia caused by Mycoplasma, Chlamydia, Legionella, fungi, parasites, viruses, or chemical etiologies (including gastric aspiration, inhalation injury).Additionally, subjects with confirmed or suspected community-acquired bacterial pneumonia (CABP) are excluded.
• \. Presence of underlying pulmonary conditions that may interfere with efficacy assessment, such as pulmonary tuberculosis, lung abscess, empyema, obstructive pneumonia, granulomatous disease, recent pulmonary embolism, moderate-to-severe bronchiectasis, severe chronic obstructive pulmonary disease, bronchial obstruction, idiopathic interstitial pneumonia, etc.
• \. Presence of other active infections that may interfere with efficacy assessment, or bacterial infectious foci requiring concomitant treatment with antibacterial agents prohibited by the study protocol, such as invasive fungal infection, endocarditis, central nervous system infection (e.g., meningitis, brain abscess, post-shunt infection), septic arthritis requiring vancomycin, etc.
• \. Severe cardiac disorders, including severe arrhythmia, significant myocardial ischemia, congestive heart failure classified as NYHA Class III-IV.
• \. Subjects with liver cirrhosis classified as Child-Pugh Class C.
• \. Subjects with documented immunodeficiency or impaired immune function, including HIV infection, hematological malignancies, bone marrow transplantation, etc.; or subjects receiving immunosuppressive therapy, including immunosuppressants, chemotherapeutic agents, drugs for prevention of transplant rejection, and corticosteroids (prednisone ≥ 20 mg/day for more than 14 days).
• \. Presence of any one of the following abnormalities: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN); AST and/or ALT \> 3 × ULN accompanied by total bilirubin \> 1.5 × ULN; creatinine clearance \< 80 mL/min (calculated using the Cockcroft-Gault formula); absolute neutrophil count \< 1 × 10⁹/L; platelet count \< 60 × 10⁹/L.
• \. Subjects with a history or evidence of severe renal disease, or receiving hemodialysis or peritoneal dialysis.
• \. Subjects presenting with shock.
• \. Subjects scheduled to undergo major surgery during the study period.
• \. Subjects with a known history of epilepsy or neuromuscular junction disorders such as myasthenia gravis.
• \. Subjects with any past or current disease, treatment, laboratory abnormality, or other condition that, in the investigator's opinion, may compromise the quality of study data or increase treatment risks during the study, e.g., subjects requiring valproic acid therapy during the study.

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jiangsu AOSAIKANG Pharm

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

Injections; Polymyxin B

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Central Study Contacts

Jiangsu Aosaikang Study Director

CONTACT

+86 02552169999; ctr-contact@ask-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 12, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): December 25, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

CN (1)