Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

NCT ID: NCT06855147

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2025-06-17

Brief Summary

This study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of HRS9531 after a single subcutaneous injection of [14C]HRS9531.

Conditions

Type 2 Diabetes Mellitus; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C]HRS9531 Group

Group Type: EXPERIMENTAL

[14C]HRS9531

Intervention Type: DRUG

A single dose of \[14C\]HRS9531 injected subcutaneously.

Interventions

[14C]HRS9531

A single dose of \[14C\]HRS9531 injected subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.

2. Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.

3. Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.

4. From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.

Exclusion Criteria

1. History of any clinically important disease or disorder.

2. History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug.

3. Physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant.

4. The subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

HRS9531-109

Identifier Type: -

Identifier Source: org_study_id