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

Recruiting now · Phase 2

Conditions studied: Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)

In brief

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

Key facts

Study ID

NCT06841731

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

100

Starts

2025-04-03

Expected to finish

2026-02-01

Last updated by the study team

2025-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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