Ventilator-associated Bacterial Pneumonia (VABP)Phase 2NCT07759934
ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
A Phase 2 study testing ASK0912 for Injection and Polymyxin B Sulfate for Injection in people with Ventilator-associated Bacterial Pneumonia (VABP) and Hospital-acquired Bacterial Pneumonia (HABP), run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Bacterial Pneumonia (VABP), Hospital-acquired Bacterial Pneumonia (HABP)
- What is being tested?
- ASK0912 for Injection and Polymyxin B Sulfate for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 25 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18-75 years on the day of informed consent signature;
- 2. Require intravenous antibiotic therapy for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
- 3. At least one clinical sign or symptom of HABP/VABP.
- 4. At least one laboratory abnormality of HABP/VABP.
- 5. Chest imaging at screening demonstrating new or progressive infiltrates consistent with pneumonia.
- 6. APACHE II score ≤ 30.
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- 7. Appropriate lower respiratory tract specimen obtained at screening for Gram stain and bacterial culture.
- 8. 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.
- 9. Women of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment.
- 10. Male subjects must use highly effective contraception throughout the study period.
Who cannot join
- 1. 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.
- 2. Subjects who have received any investigational product within 3 months prior to enrollment, or subjects who have previously participated in this clinical study.
- 3. Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only.
- 4. 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.
- 5. 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.
- 6. 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.
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- 7. Severe cardiac disorders, including severe arrhythmia, significant myocardial ischemia, congestive heart failure classified as NYHA Class III-IV.
- 8. Subjects with liver cirrhosis classified as Child-Pugh Class C.
- 9. 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).
- 10. 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.
- 11. Subjects with a history or evidence of severe renal disease, or receiving hemodialysis or peritoneal dialysis.
- 12. Subjects presenting with shock.
- 13. Subjects scheduled to undergo major surgery during the study period.
- 14. Subjects with a known history of epilepsy or neuromuscular junction disorders such as myasthenia gravis.
- 15. 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.
- 16. Subjects with any psychiatric or psychological disorder judged by the investigator to potentially increase trial risks, impair protocol compliance, or hinder study completion, such as recent (within the past 12 months) or active suicidal ideation/behavior.
- 17. Subjects judged by the investigator on clinical assessment to be at risk of death within the 7-14-day treatment phase despite adequate antibiotic therapy for pneumonia.
- 18. Female subjects who are breastfeeding or plan to breastfeed prior to the end of the study.
- 19. Any other conditions rendering the subject unsuitable for participation in this study as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu AOSAIKANG Pharm
Nanjing, Jiangsu, 210000
About this study
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
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
- Ventilator-associated Bacterial Pneumonia (VABP), Hospital-acquired Bacterial Pneumonia (HABP)
- Being tested
- ASK0912 for Injection, Polymyxin B Sulfate for Injection
- Keywords
- Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia, Polymyxin B, ASK0912
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASK0912 for InjectionDrug
ASK0912 for injection administered at a dose of 0.75 mg/kg every 12 hours
ASK0912 for InjectionDrug
ASK0912 for injection administered at a dose of 0.5 mg/kg every 8 hours
Polymyxin B Sulfate for InjectionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| ASK0912 Regimen 1 | Experimental | 0.75 mg/kg every 12 hours Receives: Drug: ASK0912 for Injection |
| ASK0912 Regimen 2 | Experimental | 0.5 mg/kg every 8 hours Receives: 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 Receives: Drug: Polymyxin B Sulfate for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 28 days
Secondary outcomes (5)
Clinical cure rate
Clinical cure rate at the EOT visit in the MITT and micro-MITT populations
Measured: Up to approximately 14 days
All-cause mortality
All-cause mortality at Day 14 in the MITT population
Measured: 14 days post-randomization
Microbiological success rate
Microbiological success rate at EOT and TOC visits in the micro-MITT populations
Measured: 28 days post-randomization
Composite clinical and microbiological cure rate
Composite clinical and microbiological cure rate at EOT and TOC visits in the micro-MITT populations
Measured: 28 days post-randomization
Early clinical response rate
Clinical response rate at OTX1 visit in the ITT and MITT populations
Measured: Day 3 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start25 Mar 2026
- Primary completion20 Oct 2027 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated Bacterial Pneumonia (VABP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759934
- Sponsor's protocol ID
- ASK0912-201
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No