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CompletedNCT07049562Updated Jul 3, 2025

Study on the Mass Balance of [14C]HRS-8427 for Injection in Healthy Chinese Subjects

A Phase 1 interventional study of HRS-8427 in Healthy Cninese Adult Male, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

To evaluate the absorption, metabolism and excretion after a single intravenous infusion of [14C]HRS-8427 in healthy Chinese subjects

02

Conditions studied

  • Healthy Cninese Adult Male
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male ages 18\~45 years, inclusive;
  2. 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;
  3. 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;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. A history of allergies to food, drugs allergic constitution;
  2. History or presence of seriousmediacl diseases judged by the investigator as not suitable for the study;
  3. Perianal diseases with regular or ongoing bloody stools, irritable bowel syndrome, and inflammatory bowel disease;
  4. Habitual constipation or diarrhea;
  5. 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;
  6. With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations
  7. Abnormal 12-lead electrocardiogram and determined by the researcher as unsuitable to participate in this study
  8. Tested positive for HIV antibodies, hepatitis B surface antigen, hepatitis C, or Treponema pallidum antibodies;
  9. 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;
  10. 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;
  11. Abuse of alcohol or drugs
  12. Heavy smokers or caffeine addicts.
  13. 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;
  14. Those who cannot accept a uniform diet or have special dietary requirements;
  15. Participants who may be unable to complete this study for other reasons or who the researcher deems should not be included.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Treatment group A: [14C] HRS-8427

    Drug: HRS-8427

Interventions

  • DrugHRS-8427

    \[14C\] HRS-8427 for injection

06

What researchers measure

Primary outcomes

  1. The total radioactive recovery rate and cumulative total radioactive recovery rate at each time interval in excreta (urine and feces)

    Time frame: 0~120hours

  2. The percentage (%AUC) of the potent drug and its metabolites in plasma, urine and feces to the administered dose

    Time frame: 0~120hours

  3. Tmax

    Time frame: 0~48hours

  4. Cmax

    Time frame: 0~48hours

  5. t1/2

    Time frame: 0~48hours

  6. MRT

    Time frame: 0~48hours

  7. AUC

    Time frame: 0~48hours

Secondary outcomes

  1. Tmax

    Time frame: 0~48hours

  2. Cmax

    Time frame: 0~48hours

  3. MRT

    Time frame: 0~48hours

  4. AUC

    Time frame: 0~48hours

  5. t1/2

    Time frame: 0~48hours

  6. Adverse events

    Time frame: 0~120hours

07

Study locations

1 site
  • First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
    Jinan, Shandong 250014, China
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07049562
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 3, 2025
Start date
May 21, 2025
Primary completion
Jun 18, 2025
Completion
Jun 18, 2025
Last update
Jul 3, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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