Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: [14C] HRS-9190

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

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
2. Male participants aged between 18 and 45 years old (inclusive);
3. ASA =I;
4. Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
5. Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

Exclusion Criteria:

1. Participants with a history of or current acute or chronic clinical diseases
2. Participants with a history of neuromuscular diseases;
3. Participants with a history of anesthetic complications;
4. Participants with a history of airway diseases;
5. Participants who have undergone major surgery within 6 months prior to screening;
6. During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
7. Participants who test positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), syphilis antibody, or human immunodeficiency virus antibody (anti-HIV);
8. Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
9. Participants with contraindications to anesthetic agents;
10. Participants who use hepatic enzyme inhibitors/inducers (within 1 month prior to dosing), vaccines (within 1 month pre-screening or planned during trial), or any drugs/health products (within 7 half-lives or 14 days pre-dosing);
11. Participants who have participated in other clinical trials and received investigational products within 3 months prior to screening, or plan to participate in other clinical trials during the trial period;
12. Participants with history of significant blood loss/transfusion (≥400 mL within 3 months), active tobacco (>5 cigarettes/day), excessive alcohol/coffee consumption, use of interfering substances (e.g., grapefruit, caffeine) within 48h prior to dosing, or evidence of drug abuse;
13. Participants with difficult venous access;
14. Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
15. Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.

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: Treatment group A: [14C] HRS-9190	Drug: [14C] HRS-9190; [14C] HRS-9190 for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta	From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma	From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose	From 0 to 120 hours after dosing
List of metabolites identified in plasma, urine, and feces	From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax	From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax	From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2	From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT	From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC	From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio	From 0 to 120 hours after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)	From 0 to 120 hours after dosing

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS-9190-103

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