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Active, not recruitingNCT06841731Updated Sep 30, 2026

A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia

A Phase 2 interventional study of HRS-8427 and Meropenem in Hospital-acquired Bacterial Pneumonia (HABP) and Ventilator-associated Bacterial Pneumonia (VABP), sponsored by Jiangsu HengRui Medicine Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Sep 30, 2026Now Active, not recruitingStart date moved+5 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.

02

Conditions studied

  • Hospital-acquired Bacterial Pneumonia (HABP)
  • Ventilator-associated Bacterial Pneumonia (VABP)
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Male and female, ≥18 years.
  3. Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
  2. Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
  3. HABP or VABP caused by obstruction.
  4. 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.
  5. Impairment of renal function with estimated glomerular filtration rate \< 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
  6. Subjects with significant laboratory abnormalities.
  7. Other pulmonary diseases that may confound the assessment of efficacy or safety.
  8. Known history of immune deficiency disease or receive immunocompromising treatment.
  9. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.
  10. Known or suspected central nervous system infections.
  11. Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.
  12. Drug abuse within 1 year prior to randomization.
  13. Judged by the Investigator, other reasons unsuitable for this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    HRS-8427

    Drug: HRS-8427

  • Active comparator
    Meropenem

    Drug: Meropenem

Interventions

  • DrugHRS-8427

    HRS-8427 for injection.

  • DrugMeropenem

    Meropenem for injection.

06

What researchers measure

Primary outcomes

  1. The all-cause mortality rate at Day 14.

    Time frame: From the first dose of the study drug to Day 14.

Secondary outcomes

  1. The all-cause mortality rate at Day 28.

    Time frame: From the first dose of the study drug to Day 28.

  2. The total ventilation time.

    Time frame: Day 14 to Day 21.

  3. The total ventilation time.

    Time frame: Day 21 to Day 28.

  4. The percentage of participants with microbiologic eradication at the early assessment (EA) period.

    Time frame: Day 4 after the start of the treatment.

  5. The percentage of participants with microbiologic eradication at the end of treatment (EOT) period.

    Time frame: Day 7 to 14.

  6. The percentage of participants with microbiologic eradication at the test of cure (TOC) period.

    Time frame: Day 14 to 21.

  7. The percentage of participants with microbiologic eradication at the follow-up (FU) period.

    Time frame: Day 21 to 28.

07

Study locations

1 site
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
08

References and documents

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 41773934 ↗
  • Wu 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Sep 30, 2026
Sites
1 site added, 1 site removed
Show site
  • China-Japan Friendship Hospital · Beijing, China
Show 1 removed
  • China-Japan Friendship Hospital · Beijing, China
Sep 30, 2026
Start date
Apr 3, 2025→Apr 10, 2025
Sep 30, 2026
Primary completion
Feb 2026→Sep 22, 2026 (actual)
Sep 30, 2026
Study completion
Feb 2026→Oct 2026
Sep 30, 2026
Enrollment
100 (estimated)→120 (actual)
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Recruiting→Active, not recruiting
    1 site added, 1 site removed
    Show site
    • China-Japan Friendship Hospital · Beijing, China
    Show 1 removed
    • China-Japan Friendship Hospital · Beijing, China
    Start date Apr 3, 2025→Apr 10, 2025
    Primary completion Feb 2026→Sep 22, 2026 (now actual)
    Study completion Feb 2026→Oct 2026
    Enrollment 100 (estimated)→120 (actual)
    + 4 other changes: index terms, verification date, contact details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06841731
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Apr 10, 2025
Primary completion
Sep 22, 2026
Completion
Oct 2026 (estimated)
Last update
Sep 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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