Hospital-acquired Bacterial Pneumonia (HABP)Phase 2NCT06841731
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
A Phase 2 study testing HRS-8427 and Meropenem in people with Hospital-acquired Bacterial Pneumonia (HABP) and Ventilator-associated Bacterial Pneumonia (VABP), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
- What is being tested?
- HRS-8427 and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 9 Oct 2026
- 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
- Be able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol.
- Male and female, ≥18 years.
- Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.
- All subjects must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia.
- Women of childbearing potential must have a negative serum pregnancy test before the first dose and must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth and sperm/ovum donation from the time of signing the informed consent form (ICF) till 14 days after the end of treatment.
Who cannot join
- Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
- Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
- HABP or VABP caused by obstruction.
- Subjects who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization.
- Impairment of renal function with estimated glomerular filtration rate < 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
- Subjects with significant laboratory abnormalities.
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- Other pulmonary diseases that may confound the assessment of efficacy or safety.
- Known history of immune deficiency disease or receive immunocompromising treatment.
- Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.
- Known or suspected central nervous system infections.
- Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.
- Drug abuse within 1 year prior to randomization.
- Judged by the Investigator, other reasons unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of HRS-8427 in the Treatment of Adults With Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP)
The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
- Being tested
- HRS-8427, Meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8427Drug
HRS-8427 for injection.
MeropenemDrug
Meropenem for injection.
| Study group | Role | What they receive |
|---|---|---|
| HRS-8427 | Experimental | Not described Receives: Drug: HRS-8427 |
| Meropenem | Active comparator | Not described Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The all-cause mortality rate at Day 14.
Measured: From the first dose of the study drug to Day 14.
Secondary outcomes (7)
The all-cause mortality rate at Day 28.
Measured: From the first dose of the study drug to Day 28.
The total ventilation time.
Measured: Day 14 to Day 21.
The total ventilation time.
Measured: Day 21 to Day 28.
The percentage of participants with microbiologic eradication at the early assessment (EA) period.
Measured: Day 4 after the start of the treatment.
The percentage of participants with microbiologic eradication at the end of treatment (EOT) period.
Measured: Day 7 to 14.
The percentage of participants with microbiologic eradication at the test of cure (TOC) period.
Measured: Day 14 to 21.
The percentage of participants with microbiologic eradication at the follow-up (FU) period.
Measured: Day 21 to 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start10 Apr 2025
- Primary completion22 Sep 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospital-acquired Bacterial Pneumonia (HABP)Studies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841731
- Sponsor's protocol ID
- HRS-8427-201
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3.
PubMed 41773934Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13.
PubMed 41528248