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Completed

NCT Number: NCT06855147

Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

This study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of HRS9531 after a single subcutaneous injection of [14C]HRS9531.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
  • Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
  • Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
  • From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.

Exclusion criteria

  • History of any clinically important disease or disorder.
  • History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug.
  • Physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant.
  • The subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.

Treatment and study plan

[14C]HRS9531

Drug

A single dose of [14C]HRS9531 injected subcutaneously.

Primary outcomes

  1. Maximum concentration (Cmax).

    Time frame: 0 to anticipated 64 days.

  2. Time to reach the maximum concentration (Tmax).

    Time frame: 0 to anticipated 64 days.

  3. Half-life (t1/2).

    Time frame: 0 to anticipated 64 days.

  4. Total radioactive recovery rate in urine.

    Time frame: 0 to anticipated 64 days.

  5. Total radioactive recovery rate in feces.

    Time frame: 0 to anticipated 64 days.

  6. Cumulative radioactive recovery rate in urine.

    Time frame: 0 to anticipated 64 days.

  7. Cumulative radioactive recovery rate in feces.

    Time frame: 0 to anticipated 64 days.

Secondary outcomes

  1. Whole blood total radioactivity (TRA) ratio.

    Time frame: 0 to anticipated 64 days.

  2. Plasma total radioactivity (TRA) ratio.

    Time frame: 0 to anticipated 64 days.

  3. Adverse events (AEs).

    Time frame: 0 to 7 days after the last sample collection.

  4. Serious adverse events (SAEs).

    Time frame: 0 to 7 days after the last sample collection.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label, Phase Ⅰ Clinical Study of the Absorption, Metabolism, and Excretion of [14C]HRS9531 in Healthy Male Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Jul 4, 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.

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