NCT06144060

A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis

A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS -8427 in patients with complicated urinary tract infection, including acute pyelonephritis.

Conditions

• Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)

Interventions

Type	Name	Description
DRUG	HRS -8427	The dose and frequency of administration were adjusted according to the eGFR.
DRUG	Imipenem and Cilastatin Sodium	The dose and frequency of administration were adjusted according to the eGFR .

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2023-11-22
• Last updated: 2023-11-22