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NCT06819488CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 7 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
6 (actual)
First submitted
5 Feb 2025
Start date
27 Feb 2025
Primary completion date
16 Apr 2025
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
NCT number
NCT06819488

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 6
  • From 27 Feb 2025 to the primary completion date, 16 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Lab values

  • 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.

Other

  • Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.