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

NCT06855147 | Completed Phase 1

• 1 other identifier: HRS9531-109
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Maximum concentration (Cmax).

  0 to anticipated 64 days.

• Time to reach the maximum concentration (Tmax).

  0 to anticipated 64 days.

• Half-life (t1/2).

  0 to anticipated 64 days.

• Total radioactive recovery rate in urine.

  0 to anticipated 64 days.

• Total radioactive recovery rate in feces.

  0 to anticipated 64 days.

• Cumulative radioactive recovery rate in urine.

  0 to anticipated 64 days.

• Cumulative radioactive recovery rate in feces.

  0 to anticipated 64 days.

Secondary Outcomes (4)

• Whole blood total radioactivity (TRA) ratio.

  0 to anticipated 64 days.

• Plasma total radioactivity (TRA) ratio.

  0 to anticipated 64 days.

• Adverse events (AEs).

  0 to 7 days after the last sample collection.

• Serious adverse events (SAEs).

  0 to 7 days after the last sample collection.

Study Arms (1)

[14C]HRS9531 Group

EXPERIMENTAL

Drug: [14C]HRS9531

Interventions

[14C]HRS9531 DRUG

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

[14C]HRS9531 Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
• Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
• Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
• 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.

You may not qualify if:

• History of any clinically important disease or disorder.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, 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 25, 2025
• First Posted: March 3, 2025
• Study Start: April 21, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

CN (1)