A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants

This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up

Study Overview

• Status: Not yet recruiting
• Conditions: Fluid Retention Due to Heart Failure
• Intervention / Treatment: Drug: [14C]HRS-9057

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Si Chen; Phone Number: 0518-82342973; Email: si.chen@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210036
      • First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )
      • Principal Investigator: Yun Liu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Informed consent was obtained voluntarily
2. Healthy males aged 18 ~ 45 years (inclusive)
3. Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)
4. Adopt efficient contraceptive measures

Exclusion Criteria:

1. Have a history of drug allergy, specific allergy, or allergic constitution
2. Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo
3. Have a history of risk factors for torsade de pointes
4. During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL/min/1.73m2
5. During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms
6. Chest X-ray findings deemed clinically significant by the investigator
7. Have positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or treponema pallidum antibody or nonnegative test result for human immunodeficiency virus (HIV) during the screening period
8. Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing
9. Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration
10. All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea
11. Workers engaged in conditions requiring long-term exposure to radioactivity; Or had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year before the trial or had participated in a radiolabeled drug trial within 1 year
12. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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: Dose Level：A; Subject will receive [14C]HRS-9057 at dose level A	Drug: [14C]HRS-9057; [14C]HRS-9057

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period	From Day 1 to Day 28
Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)	From Day 1 to Day 8
The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)	From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax	From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax	From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2	From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT	From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC	From Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax	From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax	From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2	From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT	From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC	From Day 1 to Day 28
Serious adverse events	From ICF signing date to Day 28

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS-9057-105

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