Completed

Mass Balance of [14C]HRS-7535 in Healthy Adults

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What is being tested

[14C]HRS-7535

Drug
Who is being recruted

Body Weight+8

+ Body Weight Changes

+ Diabetes Mellitus

From 18 to 45 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorShandong Suncadia Medicine Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 27, 2025

Actual date on which the first participant was enrolled.

This study aims to understand how a drug called [14C]HRS-7535 is processed in the bodies of healthy adult Chinese individuals. "Mass balance" refers to observing how the drug is absorbed, distributed, metabolized, and excreted. Such studies are vital to ensure the safety and effectiveness of medications by identifying how they behave in the human body before they are used for treating any conditions. Participants in this study will receive [14C]HRS-7535, likely through a method determined by the researchers, such as an oral or injected form. The study will track the drug's journey through the body by collecting samples, such as blood or urine, over a specified period. This helps researchers gather detailed information on the drug's breakdown and elimination, contributing to the understanding of its safety profile.

Official TitleA Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects
NCT06819488
Principal SponsorShandong Suncadia Medicine Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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.
5 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital of Nanjing Medical University

Nanjing, ChinaOpen The First Affiliated Hospital of Nanjing Medical University in Google Maps
CompletedOne Study Center
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