Health VolunteerPhase 1NCT07073157
Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。
A Phase 1 study testing HRS-8427 injection plus furosemide and HRS-8427 injection plus metformin in people with Health Volunteer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The pharmacokinetics of HRS-8427 for injection on the transporter OAT1 substrate furosemide and the MATE1/METE2-K substrate metformin were evaluated in healthy subjects. The safety of HRS-8427 for injection was evaluated in combination with furosemide and metformin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- HRS-8427 injection plus furosemide and HRS-8427 injection plus metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 15 Aug 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged from 18 to 45 years old (including 18 and 45 years old, subject to the time of signing the informed consent)
- Body weight ≥45 kg for female subjects and ≥50 kg for male subjects with body mass index (BMI) in the range of 19.0-26.0 kg/m2 (BMI = weight (kg)/height 2 (m2)), including boundary values
- Female subjects were not pregnant or lactating and had a negative pretrial pregnancy test. Male or female subjects agreed to use a highly effective contraceptive method approved by the investigator as required by the investigator (see Appendix 13 to the protocol) for the duration of the trial, with no sperm/egg donation planned (from the time of informed consent until 3 months after the last dose).
- have understood the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent
Who cannot join
- Have a history of food or drug allergy
- previous or current diseases of the heart, liver, kidney, endocrine, digestive tract, immune system, respiratory system, musculoskeletal system, and nervous system
- Plasma concentrations of sodium, potassium, magnesium and calcium were lower than the normal range and serum creatinine was not in the normal range
- Patients with fasting blood glucose below the normal range or a history of hypoglycemia.
- Abnormal 12-lead electrocardiogram and the investigator's judgment that the patient is not suitable for the study (including but not limited to QTcF > 450 ms, severe arrhythmia such as atrioventricular block of degree II or above)
- Laboratory tests (blood routine test, urine routine test, urine sediment test, blood biochemistry, coagulation function test, thyroid function test), physical examination, vital signs (temperature, blood pressure, pulse), abdominal ultrasound and chest X-ray results were judged by clinicians as clinically significant abnormalities。
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- Infectious disease tests (human immunodeficiency virus antibody, hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-treponema pallidum specific antibody) were positive。
- Patients who underwent major surgery within 3 months before screening; Or underwent surgery that may affect the in vivo course or safety evaluation of the study drug; Or planned to undergo surgery during the study period。
- Participants who had been enrolled in a drug clinical trial within 3 months before screening and had taken a trial drug, or who planned to participate in another clinical trial during the study period。
- Participants who had donated blood or had a blood loss of more than 300 mL or received a transfusion or blood product within 3 months before screening or were scheduled to donate blood during or within 1 month after the trial。
- Those who had a history of drug abuse within 3 months before screening, had a history of drug use, or had a positive screening test for drug abuse。
- The participant had any other factor that was deemed by the investigator to preclude participation in the trial
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
The pharmacokinetics of HRS-8427 for injection on the transporter OAT1 substrate furosemide and the MATE1/METE2-K substrate metformin were evaluated in healthy subjects. The safety of HRS-8427 for injection was evaluated in combination with furosemide and metformin.
- Conditions
- Health Volunteer
- Being tested
- HRS-8427 injection plus furosemide, HRS-8427 injection plus metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8427 injection plus furosemideDrug
HRS-8427 injection plus furosemide
HRS-8427 injection plus metforminDrug
HRS-8427 injection plus metformin
| Study group | Role | What they receive |
|---|---|---|
| HRS-8427 injection plus furosemide | Experimental | Not described Receives: Drug: HRS-8427 injection plus furosemide |
| HRS-8427 injection plus metformin | Experimental | Not described Receives: Drug: HRS-8427 injection plus metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: The observation lasted until the 9th day
AUC0-t
Measured: The observation lasted until the 9th day
AUC0-∞
Measured: The observation lasted until the 9th day
Tmax
Measured: The observation lasted until the 9th day
t1/2
Measured: The observation lasted until the 9th day
CL/F
Measured: The observation lasted until the 9th day
Vz/F
Measured: The observation lasted until the 9th day
Secondary outcomes (1)
adverse events
Measured: The observation lasted until the 16th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start15 Jul 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health VolunteerStudies 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
- 24 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
- NCT07073157
- Sponsor's protocol ID
- HRS-8427-106
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 28 Aug 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 41773934
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。
- ClinicalTrials.gov ID
- NCT07073157
- Acronym / sponsor ID
- HRS-8427-106
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 18 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.
The pharmacokinetics of HRS-8427 for injection on the transporter OAT1 substrate furosemide and the MATE1/METE2-K substrate metformin were evaluated in healthy subjects. The safety of HRS-8427 for injection was evaluated in combination with furosemide and metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-8427 injection plus furosemide | Experimental | Drug: HRS-8427 injection plus furosemide |
| HRS-8427 injection plus metformin | Experimental | Drug: HRS-8427 injection plus metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects aged from 18 to 45 years old (including 18 and 45 years old, subject to the time of signing the informed consent)
- Body weight ≥45 kg for female subjects and ≥50 kg for male subjects with body mass index (BMI) in the range of 19.0-26.0 kg/m2 (BMI = weight (kg)/height 2 (m2)), including boundary values
- Female subjects were not pregnant or lactating and had a negative pretrial pregnancy test. Male or female subjects agreed to use a highly effective contraceptive method approved by the investigator as required by the investigator (see Appendix 13 to the protocol) for the duration of the trial, with no sperm/egg donation planned (from the time of informed consent until 3 months after the last dose).
- have understood the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent
Key exclusion criteria (12 listed)
- Have a history of food or drug allergy
- previous or current diseases of the heart, liver, kidney, endocrine, digestive tract, immune system, respiratory system, musculoskeletal system, and nervous system
- Plasma concentrations of sodium, potassium, magnesium and calcium were lower than the normal range and serum creatinine was not in the normal range
- Patients with fasting blood glucose below the normal range or a history of hypoglycemia.
- Abnormal 12-lead electrocardiogram and the investigator's judgment that the patient is not suitable for the study (including but not limited to QTcF > 450 ms, severe arrhythmia such as atrioventricular block of degree II or above)
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-8427 injection plus furosemideHRS-8427 injection plus furosemide | Drug | HRS-8427 injection plus furosemide |
| HRS-8427 injection plus metforminHRS-8427 injection plus metformin | Drug | HRS-8427 injection plus metformin |
Primary outcome
Cmax
Time frame: The observation lasted until the 9th day
AUC0-t
Time frame: The observation lasted until the 9th day
AUC0-∞
Time frame: The observation lasted until the 9th day
Tmax
Time frame: The observation lasted until the 9th day
t1/2
Time frame: The observation lasted until the 9th day
CL/F
Time frame: The observation lasted until the 9th day
Vz/F
Time frame: The observation lasted until the 9th day
1 secondary outcome
adverse events
Time frame: The observation lasted until the 16th day
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 28 Aug 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.
- 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 injection plus furosemide and HRS-8427 injection plus metformin in people with Health Volunteer, 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 4 inclusion and 12 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 28 Aug 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: The observation lasted until the 9th day). The study lists 7 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 NCT07073157, which also lists 1 linked publication.
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 28 Aug 2025.