Clinical trial NCT06819488: A Clinical Study of Mass Balance of [14C]HRS-7535
Official title: A Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Weight Loss
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The time of maximum observed concentration (Tmax)
timeFrame: 0-120 hours.
measure: The maximum observed concentration (Cmax)
timeFrame: 0-120 hours.
measure: The terminal half-life (t1/2)
timeFrame: 0-120 hours.
measure: The total body clearance for extravascular administration (CL/F)
timeFrame: 0-120 hours.
measure: The total radioactivity ratio for blood
timeFrame: 0-96 hours.
measure: The total radioactivity ratio for plasma
timeFrame: 0-96 hours.
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: 0-11 days.
measure: Serious adverse events (AEs)
timeFrame: 0-11 days.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: