HRS-8427 / Jiangsu Hengrui Pharma - LARVOL DELTA

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

Trial completion

Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. (PubMed, Antimicrob Agents Chemother) - P1, P2, P3 | "There was minimal systemic accumulation of Cmax and AUC by dosing q8h, and the PK of HRS-8427 did not change with multiple dosing. This study indicates that both single and multiple intravenous doses of HRS-8427, up to 6,000 mg and 2,000 mg, respectively, are well tolerated in healthy subjects and show generally linear pharmacokinetics at doses up to 6,000 mg.This study is registered with the Chinese Clinical Trial registry as ChiCTR2200062570, and ClinicalTrials.gov as NCT07070375, NCT06144060, NCT06569056, NCT06841731, NCT07049562, NCT07049107, and NCT07073157."

Journal • PK/PD data • Infectious Disease

Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. (PubMed, Antimicrob Agents Chemother) - "In dialysis-dependent subjects, the systemic exposure of HRS-8427 when dosed before HD was equivalent to 50.6% of that when dosed after HD. Adverse events (AEs) were mostly mild, and RI did not appear to be associated with an increased risk of AEs.CLINICAL TRIALSThis study is registered with http://www.chinadrugtrials.org.cn/ as CTR20230658."

Journal • PK/PD data • Chronic Kidney Disease • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases

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