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

NCT06819488 | Completed Phase 1

• 1 other identifier: HRS-7535-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Weight Loss

Outcome Measures

Primary Outcomes (6)

• The time of maximum observed concentration (Tmax)

  0-120 hours.

• The maximum observed concentration (Cmax)

  0-120 hours.

• The terminal half-life (t1/2)

  0-120 hours.

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

  0-120 hours.

• The total radioactivity ratio for blood

  0-96 hours.

• The total radioactivity ratio for plasma

  0-96 hours.

Secondary Outcomes (2)

• Adverse events (AEs)

  0-11 days.

• Serious adverse events (AEs)

  0-11 days.

Study Arms (1)

[14C]HRS-7535

EXPERIMENTAL

Drug: [14C]HRS-7535

Interventions

[14C]HRS-7535 DRUG

\[14C\]HRS-7535.

[14C]HRS-7535

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Weight Loss

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: February 27, 2025
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)