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

A Single-center, Open-label, Phase Ⅰ Clinical Study of the Absorption, Metabolism, and Excretion of [14C]HRS9531 in Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Weight Loss
• Intervention / Treatment: Drug: [14C]HRS9531

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]HRS9531 Group	Drug: [14C]HRS9531; A single dose of [14C]HRS9531 injected subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Actual): June 17, 2025
• Study Completion (Actual): June 17, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Diabetes Mellitus; Weight Loss; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HRS9531-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No