RecruitingPhase 2

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

China100 participantsStarted 2025-04-03

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

The all-cause mortality rate at Day 14.

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

NCT IDNCT06841731

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

Xiaopeng Wang

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.