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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 1

Conditions: Weight Loss; Type 2 Diabetes Mellitus

Treatments: Drug: [14C]HRS-7535

Study type: Interventional

Funder types: Industry

Identifiers

NCT06819488

HRS-7535-106

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.
3. Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).
4. 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

1. 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.
2. Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.
3. 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.
4. 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.
5. Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks prior to screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[14C]HRS-7535

Experimental group

Treatment:

Drug: [14C]HRS-7535