Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)Phase 2NCT06144060

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

A Phase 2 study testing HRS -8427 and Imipenem and Cilastatin Sodium in people with Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP), run by Jiangsu HengRui Medicine Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
What is being tested?: HRS -8427 and Imipenem and Cilastatin Sodium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: No sites listed yet
Study dates: Dec 2023to Jul 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
Male and female, 18 to 75 years of age, inclusive;
Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics;
Urine specimen with evidence of pyuria；
Have urine culture specimen obtained within 48 hours prior to randomization;
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.

Who cannot join

History of significant hypersensitivity or allergic reaction to any β-lactam, or any β-lactamase inhibitors;
Known history of immune deficiency disease or receive immunocompromising treatment;
Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable condition or uncontrolled;
Known or suspected central nervous system disorder or other factors that may predispose to seizures or lower the seizures onset threshold;
Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy;
Uncomplicated lower urinary tract infection;

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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;
Patients diagnosed malignant tumors prior to randomization and currently with;
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
Urinary tract surgery prior to the randomization or urinary tract surgery planned during the study period;
Receipt of potentially effective systemic antibacterial therapy for a continuous duration of >24 hours during the previous 72 hours prior to the randomization;
History of pelvis or urinary tract trauma prior to the randomization;
Patients had severe trauma or received major surgery prior to the randomization, or surgery planned during the study period;
Impairment of renal function with estimated glomerular filtration rate <15 mL/min (calculated by the Modification of Diet in Renal Disease study equation);
Laboratory abnormalities in baseline specimens obtained at screening;
A QTcF interval prolongation at screening or abnormalities with clinical significance and may cause obvious safety risk to the subjects;
Known urine culture with at least one Gram-Negative uropathogen at ≥105 colony-forming units(CFU)/mL unsusceptible to Imipenem and Cilastatin Sodium, or only identify Gram-positive uropathogen, or confirmed fungal urinary tract infection with ≥103CFU/mL;
Indwelling catheter or urinary tract instrument, in the opinion of the Investigator, incapable of removal during the study period;
Likely to require the use of antibiotic for cUTI or AP prophylaxis after treatment;
Suspected of sepsis, producing life-threatening organ dysfunction;
Estimated survival within 6 weeks or rapidly progressive or end stage disease with high mortality rate;
Drug abuse prior to the randomization;
Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;
In the judgment of the Investigator, other reasons unsuitable for study.

Trial locations and contacts

No sites are listed yet.

Xiaopeng Wang contact

+86-182-6038-7118

xiaopeng.wang@hengrui.com

About this study

Official title: 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

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)
Being tested: HRS -8427, Imipenem and Cilastatin Sodium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS -8427Drug
The dose and frequency of administration were adjusted according to the eGFR.
Imipenem and Cilastatin SodiumDrug
The dose and frequency of administration were adjusted according to the eGFR .

Study groups in NCT06144060
Study group	Role	What they receive
Treatment group A：HRS-8427	Experimental	Not described Receives: Drug: HRS -8427
Treatment group B：HRS-8427	Experimental	Not described Receives: Drug: HRS -8427
Imipenem and Cilastatin Sodium	Active comparator	Not described Receives: Drug: Imipenem and Cilastatin Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
Measured: Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)

Secondary outcomes (5)

Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment（EA）、End of Treatment（EOT）and Late Follow-Up (LFU)
Measured: EA : Day 4、EOT: Day 7 to Day 14、LFU：Day 21 to Day 28
Percentage of Participants With Microbiological Eradication at EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Measured: EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Percentage of Participants With Microbiological Eradication at EA （Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment） Per Uropathogen
Measured: EA （Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment） Per Uropathogen
Percentage of Participants With Clinical Response at EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Measured: EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Percentage of Participants With Clinical Response at EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU （14 days after end of treatment）Per Uropathogen
Measured: EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU （14 days after end of treatment）Per Uropathogen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2023Jul 2024

First posted22 Nov 2023
Study startDec 2023 (estimated)
Primary completionJun 2024 (estimated)
Study completionJul 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)Studies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 126 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06144060
Sponsor's protocol ID: HRS-8427-202
Status last verified: Nov 2023
First submitted: 16 Nov 2023
Last updated: 22 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3.
PubMed 41773934
Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13.
PubMed 41528248
Cao Y, Huang Y, Xie J, Wu Q, Yang S, Yang X, Huang J, Liu J, Meng J, Yang G. Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0070225. doi: 10.1128/aac.00702-25. Epub 2025 Nov 6.
PubMed 41196282

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06144060
Acronym / sponsor ID: HRS-8427-202
Conditions: Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 126 participants (estimated)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2023 (estimated)
Primary completion: Jun 2024 (estimated)
Study completion: Jul 2024 (estimated)
First posted: 22 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment group A：HRS-8427	Experimental	Drug: HRS -8427
Treatment group B：HRS-8427	Experimental	Drug: HRS -8427
Imipenem and Cilastatin Sodium	Active comparator	Drug: Imipenem and Cilastatin Sodium

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;
Male and female, 18 to 75 years of age, inclusive;
Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics;
Urine specimen with evidence of pyuria；
Have urine culture specimen obtained within 48 hours prior to randomization;

Key exclusion criteria (24 listed)

History of significant hypersensitivity or allergic reaction to any β-lactam, or any β-lactamase inhibitors;
Known history of immune deficiency disease or receive immunocompromising treatment;
Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable condition or uncontrolled;
Known or suspected central nervous system disorder or other factors that may predispose to seizures or lower the seizures onset threshold;
Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS -8427The dose and frequency of administration were adjusted according to the eGFR.	Drug	Treatment group A：HRS-8427, Treatment group B：HRS-8427
Imipenem and Cilastatin SodiumThe dose and frequency of administration were adjusted according to the eGFR .	Drug	Imipenem and Cilastatin Sodium

Primary outcome

Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
Time frame: Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)

5 secondary outcomes

Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment（EA）、End of Treatment（EOT）and Late Follow-Up (LFU)
Time frame: EA : Day 4、EOT: Day 7 to Day 14、LFU：Day 21 to Day 28
Percentage of Participants With Microbiological Eradication at EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Time frame: EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Percentage of Participants With Microbiological Eradication at EA （Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment） Per Uropathogen
Time frame: EA （Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment） Per Uropathogen
Percentage of Participants With Clinical Response at EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Time frame: EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）
Percentage of Participants With Clinical Response at EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU （14 days after end of treatment）Per Uropathogen
Time frame: EA（Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU （14 days after end of treatment）Per Uropathogen

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Derived from this study: PubMed 41773934Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3.
Derived from this study: PubMed 41528248Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13.
Derived from this study: PubMed 41196282Cao Y, Huang Y, Xie J, Wu Q, Yang S, Yang X, Huang J, Liu J, Meng J, Yang G. Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0070225. doi: 10.1128/aac.00702-25. Epub 2025 Nov 6.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaopeng Wang contact

+86-182-6038-7118

xiaopeng.wang@hengrui.com

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaopeng Wang (+86-182-6038-7118, xiaopeng.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC) (time frame: Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06144060, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.