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NCT Number: NCT07681479

A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants

This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )

Nanjing, Jiangsu, 210036, China

Location contact

Yun Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informed consent was obtained voluntarily
  • Healthy males aged 18 ~ 45 years (inclusive)
  • Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)
  • Adopt efficient contraceptive measures

Exclusion criteria

  • Have a history of drug allergy, specific allergy, or allergic constitution
  • Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo
  • Have a history of risk factors for torsade de pointes
  • During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL/min/1.73m2
  • During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms
  • Chest X-ray findings deemed clinically significant by the investigator
  • Have positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or treponema pallidum antibody or nonnegative test result for human immunodeficiency virus (HIV) during the screening period
  • Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing
  • Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration
  • All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea
  • Workers engaged in conditions requiring long-term exposure to radioactivity; Or had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year before the trial or had participated in a radiolabeled drug trial within 1 year
  • Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment

Treatment and study plan

[14C]HRS-9057

Drug

[14C]HRS-9057

Primary outcomes

  1. Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period

    Time frame: From Day 1 to Day 28

  2. Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)

    Time frame: From Day 1 to Day 8

  3. The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)

    Time frame: From Day 1 to Day 28

  4. Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax

    Time frame: From Day 1 to Day 28

  5. Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax

    Time frame: From Day 1 to Day 28

  6. Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2

    Time frame: From Day 1 to Day 28

  7. Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT

    Time frame: From Day 1 to Day 28

  8. Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC

    Time frame: From Day 1 to Day 28

Secondary outcomes

  1. Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax

    Time frame: From Day 1 to Day 28

  2. Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax

    Time frame: From Day 1 to Day 28

  3. Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2

    Time frame: From Day 1 to Day 28

  4. Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT

    Time frame: From Day 1 to Day 28

  5. Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC

    Time frame: From Day 1 to Day 28

  6. Serious adverse events

    Time frame: From ICF signing date to Day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

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.