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

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.

Study Overview

• Status: Recruiting
• Conditions: Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP)
• Intervention / Treatment: Drug: HRS-8427; Drug: Meropenem

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaopeng Wang; Phone Number: +86-0518-81220121; Email: xiaopeng.wang@hengrui.com
• Study Contact Backup: Name: Yaru Wei; Phone Number: +86-010-67166319; Email: yaru.wei.yw37@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Bin Cao; Phone Number: +86-010-84206185; Email: caobin_ben@163.com
      • Principal Investigator: Bin Cao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meropenem	Drug: Meropenem; Meropenem for injection.
Experimental: HRS-8427	Drug: HRS-8427; HRS-8427 for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The all-cause mortality rate at Day 14.	From the first dose of the study drug to Day 14.

Secondary Outcome Measures

Outcome Measure	Time Frame
The all-cause mortality rate at Day 28.	From the first dose of the study drug to Day 28.
The total ventilation time.	Day 14 to Day 21.
The total ventilation time.	Day 21 to Day 28.
The percentage of participants with microbiologic eradication at the early assessment (EA) period.	Day 4 after the start of the treatment.
The percentage of participants with microbiologic eradication at the end of treatment (EOT) period.	Day 7 to 14.
The percentage of participants with microbiologic eradication at the test of cure (TOC) period.	Day 14 to 21.
The percentage of participants with microbiologic eradication at the follow-up (FU) period.	Day 21 to 28.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Anti-Bacterial Agents; Anti-Infective Agents; Meropenem
• Other Study ID Numbers: HRS-8427-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No