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

Inclusion Criteria:

1. Able and willing to provide a written informed consent before the study, fullyunderstand the study and be able to complete the study according to the protocol;

2. Male and female, ≥18 years;

3. Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that thepatients will require hospitalization and initial treatment with intravenousantibiotics;

4. Urine specimen with evidence of pyuria；

5. Have urine culture specimen obtained within 48 hours prior to randomization;

6. 48 hours before random, allowing a short course of antimicrobial drug treatment isless than 24 hours (random rate ≤25%)

7. Women of childbearing potential must have a negative serum pregnancy test beforefirst dose, must be non-lactating. Fertile female subjects or male subjects whosepartner 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 daysafter 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 andunstable condition or uncontrolled;

4. Known or suspected central nervous system disorder or other factors that maypredispose to seizures or lower the seizures onset threshold;

5. Presence of any known or suspected disease or condition that, in the opinion of theInvestigator, 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 medicalhistory and/or physical examination;

8. Patients received cancer treatment within 4 weeks before randomization or plannedtreatment during the study period;

9. Systemic antimicrobial therapy other than the investigational drug need to be usedduring the study period, with the exception of topical or single oral dose ofantifungal treatment

10. Urinary tract surgery prior to 7 days before randomization or surgery planned duringthe study period;

11. Indwelling catheter or urinary apparatus, the researchers determine drug treatmentperiod cannot be removed;

12. Receipt of potentially effective systemic antibacterial therapy for a continuousduration of ≥24 hours during the previous 48 hours prior to the randomization;

13. History of pelvis or urinary tract trauma prior to the randomization;

14. Patients had severe trauma or received major surgery prior to the randomization;

15. Impairment of renal function with estimated glomerular filtration rate or CreatinineClearance <15 mL/min ;

16. Laboratory abnormalities in baseline specimens obtained at screening;

17. A QTcF interval prolongation at screening or abnormalities with clinicalsignificance and may cause obvious safety risk to the subjects;

18. Known urine culture with at least one Gram-Negative uropathogen at ≥105colony-forming units(CFU)/mL unsusceptible to Imipenem and Cilastatin Sodium, oronly identify Gram-positive uropathogen, or confirmed fungal urinary tract infectionwith ≥103CFU/mL;

19. Likely to require the use of antibiotic drug prevention after treatment;

20. Suspected of sepsis, producing life-threatening organ dysfunction;

21. Estimated survival within 6 weeks or rapidly progressive or end stage disease withhigh mortality rate;

22. Drug abuse prior to the randomization;

23. Participated in a previous clinical study related to HRS-8427 and used HRS-8427 orhave participated in another clinical study within 4 weeks before randomization andused a study drug containing the active ingredient;

24. Judgment of the Investigator, other reasons unsuitable for study.