HRS-8427 / Jiangsu Hengrui Pharma - LARVOL DELTA

Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. (PubMed, Antimicrob Agents Chemother) - P1 | "Safety assessments indicated an overall favorable tolerability profile, with most adverse events being mild in severity. Based on PK and microbiological data, a 2,000 mg regimen achieved concentrations exceeding the MIC₉₀ values of major Gram-negative pathogens, supporting further clinical development of HRS-8427 for respiratory and other Gram-negative bacterial infections.CLINICAL TRIALSThis study is registered with Chinese Clinical Trial Registry Platform as ChiCTR2300072350."

Journal • PK/PD data • Infectious Disease

Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion

Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial

Pharmacokinetics and Safety of HRS-8427 in Healthy Volunteers and in Patients With Impaired Renal Function (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Infectious Disease • Renal Disease

Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial

Study on the Mass Balance of [14C]HRS-8427 for Injection in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial

A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumonia • Respiratory Diseases

HRS-8427 versus imipenem-cilastatin for complicated urinary tract infections: a randomised, double-blind phase 2 study (ESCMID Global 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Infectious Disease • Nephrology

A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Infectious Disease • Pneumonia • Respiratory Diseases

A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis (clinicaltrials.gov) - P3 | N=578 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Nephrology

A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis (clinicaltrials.gov) - P3 | N=578 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial • Infectious Disease • Nephrology

A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Nephrology