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

NCT06841731 | Recruiting Phase 2

• 1 other identifier: HRS-8427-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Outcome Measures

Primary Outcomes (1)

• The all-cause mortality rate at Day 14.

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

Secondary Outcomes (7)

• 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.

Study Arms (2)

HRS-8427

EXPERIMENTAL

Drug: HRS-8427

Meropenem

ACTIVE COMPARATOR

Drug: Meropenem

Interventions

HRS-8427 DRUG

HRS-8427 for injection.

HRS-8427

Meropenem DRUG

Meropenem for injection.

Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

Meropenem

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaopeng Wang

CONTACT

+86-0518-81220121; xiaopeng.wang@hengrui.com

Yaru Wei

CONTACT

+86-010-67166319; yaru.wei.yw37@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: April 3, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

CN (1)