Healthy Cninese Adult MalePhase 1NCT07049562
Study on the Mass Balance of [14C]HRS-8427 for Injection in Healthy Chinese Subjects
A Phase 1 study testing HRS-8427 in people with Healthy Cninese Adult Male, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the absorption, metabolism and excretion after a single intravenous infusion of [14C]HRS-8427 in healthy Chinese subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Cninese Adult Male
- What is being tested?
- HRS-8427
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2025to 18 Jun 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male ages 18~45 years, inclusive;
- The body weight should be no less than 50 kg, and the body mass index (BMI) should be within the range of 19.0 kg/m2 to 26.0 kg/m2, inclusive;
- Subjects without sperm donation or fertility plan, and agree to adopt highly medically effective contraceptive measurements during the trial and within 3 months after the last dose;
- Participants voluntarily sign the informed consent form before the trial, can communicate well with the researcher, have a full understanding of the trial content, process and possible adverse reactions, and can complete the trial in accordance with the protocol.
Who cannot join
- A history of allergies to food, drugs allergic constitution;
- History or presence of seriousmediacl diseases judged by the investigator as not suitable for the study;
- Perianal diseases with regular or ongoing bloody stools, irritable bowel syndrome, and inflammatory bowel disease;
- Habitual constipation or diarrhea;
- 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;
- With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations
Show all 15Show fewer
- Abnormal 12-lead electrocardiogram and determined by the researcher as unsuitable to participate in this study
- Tested positive for HIV antibodies, hepatitis B surface antigen, hepatitis C, or Treponema pallidum antibodies;
- Those who have used other clinical trial drugs within 3 months before the trial or plan to participate in other clinical trials during this study period;
- Those have experienced blood loss or donated up to 300 mL of blood, or have received blood transfusion or used blood products, or plan to donate blood during the trial or within 1 month after the end of the trial;
- Abuse of alcohol or drugs
- Heavy smokers or caffeine addicts.
- Those engaged in long-term exposure to radioactive conditions; Or those who have had significant radioactive exposure within one year before the test or have participated in radiopharmaceutical tests within one year;
- Those who cannot accept a uniform diet or have special dietary requirements;
- Participants who may be unable to complete this study for other reasons or who the researcher deems should not be included.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014
About this study
To evaluate the absorption, metabolism and excretion after a single intravenous infusion of [14C]HRS-8427 in healthy Chinese subjects
- Conditions
- Healthy Cninese Adult Male
- 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
[14C] HRS-8427 for injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: [14C] 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.
The total radioactive recovery rate and cumulative total radioactive recovery rate at each time interval in excreta (urine and feces)
Measured: 0~120hours
The percentage (%AUC) of the potent drug and its metabolites in plasma, urine and feces to the administered dose
Measured: 0~120hours
Tmax
Measured: 0~48hours
Cmax
Measured: 0~48hours
t1/2
Measured: 0~48hours
MRT
Measured: 0~48hours
AUC
Measured: 0~48hours
Secondary outcomes (6)
Tmax
Measured: 0~48hours
Cmax
Measured: 0~48hours
MRT
Measured: 0~48hours
AUC
Measured: 0~48hours
t1/2
Measured: 0~48hours
Adverse events
Measured: 0~120hours
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 start21 May 2025
- Primary completion18 Jun 2025
- Study completion18 Jun 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 Healthy Cninese Adult MaleStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT07049562
- Sponsor's protocol ID
- HRS-8427-104
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 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 41773934
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mass Balance of [14C]HRS-8427 for Injection in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07049562
- Acronym / sponsor ID
- HRS-8427-104
- Conditions
- Healthy Cninese Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 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.
To evaluate the absorption, metabolism and excretion after a single intravenous infusion of [14C]HRS-8427 in healthy Chinese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: [14C] HRS-8427 | Experimental | Drug: HRS-8427 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male ages 18~45 years, inclusive;
- The body weight should be no less than 50 kg, and the body mass index (BMI) should be within the range of 19.0 kg/m2 to 26.0 kg/m2, inclusive;
- Subjects without sperm donation or fertility plan, and agree to adopt highly medically effective contraceptive measurements during the trial and within 3 months after the last dose;
- Participants voluntarily sign the informed consent form before the trial, can communicate well with the researcher, have a full understanding of the trial content, process and possible adverse reactions, and can complete the trial in accordance with the protocol.
Key exclusion criteria (15 listed)
- A history of allergies to food, drugs allergic constitution;
- History or presence of seriousmediacl diseases judged by the investigator as not suitable for the study;
- Perianal diseases with regular or ongoing bloody stools, irritable bowel syndrome, and inflammatory bowel disease;
- Habitual constipation or diarrhea;
- 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;
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[14C] HRS-8427 for injection | Drug | Treatment group A: [14C] HRS-8427 |
Primary outcome
The total radioactive recovery rate and cumulative total radioactive recovery rate at each time interval in excreta (urine and feces)
Time frame: 0~120hours
The percentage (%AUC) of the potent drug and its metabolites in plasma, urine and feces to the administered dose
Time frame: 0~120hours
Tmax
Time frame: 0~48hours
Cmax
Time frame: 0~48hours
t1/2
Time frame: 0~48hours
MRT
Time frame: 0~48hours
AUC
Time frame: 0~48hours
6 secondary outcomes
Tmax
Time frame: 0~48hours
Cmax
Time frame: 0~48hours
MRT
Time frame: 0~48hours
AUC
Time frame: 0~48hours
t1/2
Time frame: 0~48hours
Adverse events
Time frame: 0~120hours
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 3 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.
- 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.
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 Healthy Cninese Adult Male, 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 15 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 3 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?
The total radioactive recovery rate and cumulative total radioactive recovery rate at each time interval in excreta (urine and feces) (time frame: 0~120hours). 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 NCT07049562, 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 3 Jul 2025.