Skip to main content
OpenTrials
Completed

NCT Number: NCT07049562

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

HRS-8427

Drug

[14C] HRS-8427 for injection

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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.