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Completed

NCT Number: NCT06819488

A Clinical Study of Mass Balance of [14C]HRS-7535

The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must voluntarily sign the informed consent form (ICF) prior to any activities related to the study, demonstrate understanding of the study procedures and methods, and commit to strictly adhering to the clinical trial protocol to complete the study.
  • Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.
  • Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).
  • Male subjects with female partners of childbearing potential must have no plans for procreation or sperm donation from the time of signing the informed consent until one year after the last dose of the study drug. They must also agree to use highly effective contraception methods (including their partners) during this period.

Exclusion criteria

  • Subjects with abnormalities identified through a comprehensive physical examination, vital signs assessment, laboratory tests, chest X-ray, 12-lead ECG, or abdominal ultrasound that are deemed clinically significant by the investigator.
  • Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.
  • Subjects who test positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antigen/antibody combination, or syphilis-specific antibodies.
  • Subjects with a history of drug abuse, drug dependence (based on medical history), or those who test positive for drug abuse during urine screening prior to dosing.
  • Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks prior to screening.

Treatment and study plan

[14C]HRS-7535

Drug

[14C]HRS-7535.

Primary outcomes

  1. The time of maximum observed concentration (Tmax)

    Time frame: 0-120 hours.

  2. The maximum observed concentration (Cmax)

    Time frame: 0-120 hours.

  3. The terminal half-life (t1/2)

    Time frame: 0-120 hours.

  4. The total body clearance for extravascular administration (CL/F)

    Time frame: 0-120 hours.

  5. The total radioactivity ratio for blood

    Time frame: 0-96 hours.

  6. The total radioactivity ratio for plasma

    Time frame: 0-96 hours.

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: 0-11 days.

  2. Serious adverse events (AEs)

    Time frame: 0-11 days.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
May 7, 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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