Gram-negative Bacterial InfectionsPhase 1NCT07070375
Pharmacokinetics and Safety of HRS-8427 in Healthy Volunteers and in Patients With Impaired Renal Function
A Phase 1 study testing HRS-8427 in people with Gram-negative Bacterial Infections, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal function as controls, to inform clinical dosing in patients with renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gram-negative Bacterial Infections
- What is being tested?
- HRS-8427
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2023to 23 Aug 2023
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged between 18 and 70 years old (including the boundary values);
- The body weight of male subjects should be ≥ 50.0 kg, and that of female subjects should be ≥ 45.0 kg. The body mass index (BMI = body weight (kg) / height² (m²)) should be between 18.0 and 32.0 kg/m² (including the boundary values);
- The estimated glomerular filtration rate (eGFR) (estimated by the MDRD formula) needs to meet the following criteria:
- For subjects with normal renal function: ≥ 90 mL/min and < 130 mL/min For subjects with mild renal insufficiency: 60 - 89 mL/min (including the boundary values) For subjects with moderate renal insufficiency: 30 - 59 mL/min (including the boundary values) For subjects with severe renal insufficiency: 15 - 29 mL/min (including the boundary values) For subjects with end-stage renal failure on maintenance dialysis: < 15 mL/min
- The renal function status is stable. The interval between two detections during the screening period should be at least 72 hours (the result of the first detection can adopt the in-hospital or out-of-hospital detection result within 30 days before the second detection), and the absolute value of the fluctuation between the two detection results is less than 30%. Calculation formula: (the result of the second detection - the result of the first detection) / the result of the first detection;
- Female subjects with fertility or male subjects whose partners are fertile females should have no plan for childbearing, donating sperm/eggs from the time of signing the informed consent form to 1 month after the last administration, and voluntarily take effective contraceptive measures (including partners) (non-drug contraception is required during the trial period).
Who cannot join
- Subjects with a history of allergy to cephalosporins or penicillin, or those with specific allergic history (such as asthma, urticaria, eczema, etc.), or those with allergic constitution (such as being allergic to two or more drugs, foods and pollens);
- Subjects who have undergone major surgeries within 3 months before screening, or those who have received surgeries that may significantly affect the in vivo process of the study drug or the evaluation of its safety, or those who plan to undergo surgeries during the trial period;
- Subjects with a history of kidney transplantation or those who are expected to need kidney transplantation during the trial period;
- Subjects who have been enrolled in any clinical trials as subjects within 3 months before screening;
- Subjects with a positive result in any one of the tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) during the screening period;
- From 48 hours before taking the study drug until the end of the study, subjects refuse to stop consuming any beverages or foods containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, grapefruit and beverages containing this ingredient, etc.);
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- Subjects who frequently drink alcohol within 6 months before screening (that is, female subjects who drink more than 14 standard units of alcohol per week, and male subjects who drink more than 21 standard units of alcohol per week (1 standard unit contains 14g of alcohol, such as 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine)) or those who cannot refrain from drinking alcohol during the trial period;
- Subjects with abnormal results of 12-lead electrocardiogram that are judged by the research doctor to be clinically significant or with a corrected QTcF ≥ 450 ms, etc.;
- Subjects who cannot refrain from smoking during the trial period;
- Subjects with a history of drug abuse/drug use.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Multicenter, Parallel-Group, Open-Label Study of Pharmacokinetics and Safety of HRS-8427 Injection in Chinese Subjects With Renal Impairment
This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal function as controls, to inform clinical dosing in patients with renal impairment.
- Conditions
- Gram-negative Bacterial Infections
- Being tested
- HRS-8427
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8427Drug
HRS-8427
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Healthy volunteer with stable normal renal function Receives: Drug: HRS-8427 |
| Cohort B | Experimental | Patient with stable mild renal impairment Receives: Drug: HRS-8427 |
| Cohort C | Experimental | Patient with stable moderate renal impairment Receives: Drug: HRS-8427 |
| Cohort D | Experimental | Patient with stable severe renal impairment Receives: Drug: HRS-8427 |
| Cohort E | Experimental | Patient with end-stage renal failure. Receives: Drug: HRS-8427 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
observed maximum plasma concentration. Blood samples will be collected.
Measured: 4 days
AUC0-t
area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Measured: 4 days
AUC0-∞
area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Measured: 4 days
Tmax
observed time to reach Cmax. Blood samples will be collected.
Measured: 4 days
Ae: amount excreted. Urine samples will be collected.
Measured: 4 days
Secondary outcomes (1)
Incidence of treatment emergent AEs (TEAEs)
Measured: no more than 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start19 Apr 2023
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gram-negative Bacterial InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070375
- Sponsor's protocol ID
- HRS-8427-102
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- 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 41773934Cao 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Parallel-Group, Open-Label Study of Pharmacokinetics and Safety of HRS-8427 Injection in Chinese Subjects With Renal Impairment
- ClinicalTrials.gov ID
- NCT07070375
- Acronym / sponsor ID
- HRS-8427-102
- Conditions
- Gram-negative Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 17 Jul 2025 (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.
This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal function as controls, to inform clinical dosing in patients with renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: HRS-8427Healthy volunteer with stable normal renal function |
| Cohort B | Experimental | Drug: HRS-8427Patient with stable mild renal impairment |
| Cohort C | Experimental | Drug: HRS-8427Patient with stable moderate renal impairment |
| Cohort D | Experimental | Drug: HRS-8427Patient with stable severe renal impairment |
| Cohort E | Experimental | Drug: HRS-8427Patient with end-stage renal failure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged between 18 and 70 years old (including the boundary values);
- The body weight of male subjects should be ≥ 50.0 kg, and that of female subjects should be ≥ 45.0 kg. The body mass index (BMI = body weight (kg) / height² (m²)) should be between 18.0 and 32.0 kg/m² (including the boundary values);
- The estimated glomerular filtration rate (eGFR) (estimated by the MDRD formula) needs to meet the following criteria:
- For subjects with normal renal function: ≥ 90 mL/min and < 130 mL/min For subjects with mild renal insufficiency: 60 - 89 mL/min (including the boundary values) For subjects with moderate renal insufficiency: 30 - 59 mL/min (including the boundary values) For subjects with severe renal insufficiency: 15 - 29 mL/min (including the boundary values) For subjects with end-stage renal failure on maintenance dialysis: < 15 mL/min
- The renal function status is stable. The interval between two detections during the screening period should be at least 72 hours (the result of the first detection can adopt the in-hospital or out-of-hospital detection result within 30 days before the second detection), and the absolute value of the fluctuation between the two detection results is less than 30%. Calculation formula: (the result of the second detection - the result of the first detection) / the result of the first detection;
Key exclusion criteria (10 listed)
- Subjects with a history of allergy to cephalosporins or penicillin, or those with specific allergic history (such as asthma, urticaria, eczema, etc.), or those with allergic constitution (such as being allergic to two or more drugs, foods and pollens);
- Subjects who have undergone major surgeries within 3 months before screening, or those who have received surgeries that may significantly affect the in vivo process of the study drug or the evaluation of its safety, or those who plan to undergo surgeries during the trial period;
- Subjects with a history of kidney transplantation or those who are expected to need kidney transplantation during the trial period;
- Subjects who have been enrolled in any clinical trials as subjects within 3 months before screening;
- Subjects with a positive result in any one of the tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) during the screening period;
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-8427HRS-8427 | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Cmax
Time frame: 4 days
observed maximum plasma concentration. Blood samples will be collected.
AUC0-t
Time frame: 4 days
area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
AUC0-∞
Time frame: 4 days
area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Tmax
Time frame: 4 days
observed time to reach Cmax. Blood samples will be collected.
Ae: amount excreted. Urine samples will be collected.
Time frame: 4 days
1 secondary outcome
Incidence of treatment emergent AEs (TEAEs)
Time frame: no more than 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- 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 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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-8427 in people with Gram-negative Bacterial Infections, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 10 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: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 4 days). The study lists 5 primary outcomes in all. 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 NCT07070375, which also lists 2 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 17 Jul 2025.