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

UNKNOWNPHASE2

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

NCT06144060•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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;
•2. Male and female, 18 to 75 years of age, inclusive;
•3. Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics;
•4. Urine specimen with evidence of pyuria；
•5. Have urine culture specimen obtained within 48 hours prior to randomization;
•6. Women of childbearing potential must have a negative serum pregnancy test before first dose, 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, sperm/ovum donation from the time of signed ICF till 14 days after end of treatment.

Exclusion Criteria

•1. History of significant hypersensitivity or allergic reaction to any β-lactam, or any β-lactamase inhibitors;
•2. Known history of immune deficiency disease or receive immunocompromising treatment;
•3. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable condition or uncontrolled;
•4. Known or suspected central nervous system disorder or other factors that may predispose to seizures or lower the seizures onset threshold;
•5. Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy;
•6. Uncomplicated lower urinary tract infection;
•7. Suspected or confirmed urinary tract symptoms caused by acute/chronic prostatitis, orchitis, epididymitis or sexually transmitted diseases as determined by medical history and/or physical examination;
•8. Patients diagnosed malignant tumors prior to randomization and currently with;
•9. Systemic antimicrobial therapy other than the investigational drug need to be used during the study period, with the exception of topical or single oral dose of antifungal treatment
•10. Urinary tract surgery prior to the randomization or urinary tract surgery planned during the study period;
+14 more criteria

Key Dates

Start Date

December 1, 2023

Primary Completion Date

June 1, 2024

Completion Date

July 1, 2024

Last Updated

November 22, 2023

Enrollment

126

ESTIMATED participants

Conditions

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

Interventions

HRS -8427

DRUG

Imipenem and Cilastatin Sodium

DRUG

Contacts

Xiaopeng Wang

CONTACT

+86-182-6038-7118 xiaopeng.wang@hengrui.com