Health VolunteerPhase 1NCT07049107
Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects
A Phase 1 study testing HRS-8427 in people with Health Volunteer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label, sequential drug interaction study The primary objectives are: To evaluate the pharmacokinetic effects of HRS-8427 injection on the liver drug enzymes CYP2B6 substrate bupropion and CYP3A4 substrate midazolam in healthy subjects. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 21 Jul 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 subjects aged 18 to 45 years old (including 18 and 45 years old, based on the time of signing the informed consent form), both male and female.
- The weight of female subjects was ≥45 kg, the weight of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-26.0 kg/m2
- The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
- Before the trial, a thorough understanding of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial was obtained. The participant voluntarily participated in this clinical trial, was able to communicate well with the researcher, comply with the requirements of the entire study, and signed a written informed consent form.
Who cannot join
- Those with a history of allergies to food, drugs, etc., especially those known to be allergic to β -lactam antibacterial drugs and midazolam, bupropion, or those with an allergic constitution.
- Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc.
- Conforming to the contraindications of midazolam use or not suitable for midazolam use .
- Comply with the contraindications for bupropion use or are not suitable for bupropion use .
- The 12-lead electrocardiogram was abnormal and was judged by the researcher as unsuitable to participate in this study .
- Laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), physical examination, vital signs (ears, blood pressure, pulse, respiration), and chest X-ray results, etc., which are judged by clinicians as abnormal and of clinical significance .
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- Those with positive infectious disease tests (human immunodeficiency virus antibody, hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum specific antibody).
- Those who have undergone major surgical operations within the three months prior to screening; Or those who have undergone surgery that may affect the in vivo process or safety evaluation of the studied drug; Or those who plan to undergo surgical operations during the research period.
- Those who have participated in drug clinical trials as subjects and taken the investigational drug within 3 months prior to screening, or who plan to participate in other clinical trials during this study period .
- Those who have used any inducers or inhibitors of CYP2B6 and CYP3A enzymes within one month before taking the study drug for the first time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Pharmacokinetic Effects of HRS-8427 Injection on Bupropion and Midazolam in Healthy Subjects
This study is a single-center, open-label, sequential drug interaction study
The primary objectives are:
To evaluate the pharmacokinetic effects of HRS-8427 injection on the liver drug enzymes CYP2B6 substrate bupropion and CYP3A4 substrate midazolam in healthy subjects.
- Conditions
- Health Volunteer
- Being tested
- HRS-8427
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 |
|---|---|---|
| HRS-8427 | Experimental | Not described Receives: Drug: HRS-8427 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed maximum plasma concentration. Blood samples will be collected.
Measured: 15 Days
AUC0-t
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Measured: 15 Days
AUC0-∞
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Measured: 15 Days
Tmax
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed time to reach Cmax. Blood samples will be collected.
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start23 Jun 2025
- Primary completion21 Jul 2025
- Study completion21 Jul 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT07049107
- Sponsor's protocol ID
- HRS-8427-105
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Pharmacokinetic Effects of HRS-8427 Injection on Bupropion and Midazolam in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07049107
- Acronym / sponsor ID
- HRS-8427-105
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 3 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 is a single-center, open-label, sequential drug interaction study
The primary objectives are:
To evaluate the pharmacokinetic effects of HRS-8427 injection on the liver drug enzymes CYP2B6 substrate bupropion and CYP3A4 substrate midazolam in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-8427 | Experimental | Drug: HRS-8427 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 18 to 45 years old (including 18 and 45 years old, based on the time of signing the informed consent form), both male and female.
- The weight of female subjects was ≥45 kg, the weight of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-26.0 kg/m2
- The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
- Before the trial, a thorough understanding of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial was obtained. The participant voluntarily participated in this clinical trial, was able to communicate well with the researcher, comply with the requirements of the entire study, and signed a written informed consent form.
Key exclusion criteria (10 listed)
- Those with a history of allergies to food, drugs, etc., especially those known to be allergic to β -lactam antibacterial drugs and midazolam, bupropion, or those with an allergic constitution.
- Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc.
- Conforming to the contraindications of midazolam use or not suitable for midazolam use .
- Comply with the contraindications for bupropion use or are not suitable for bupropion use .
- The 12-lead electrocardiogram was abnormal and was judged by the researcher as unsuitable to participate in this study .
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 | HRS-8427 |
Primary outcome
Cmax
Time frame: 15 Days
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed maximum plasma concentration. Blood samples will be collected.
AUC0-t
Time frame: 15 Days
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. 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: 15 Days
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Tmax
Time frame: 15 Days
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed time to reach Cmax. Blood samples will be collected.
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 16 Mar 2026.
- 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 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 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 16 Mar 2026. 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: 15 Days). The study lists 4 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 NCT07049107, 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 16 Mar 2026.