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

April 22, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A: [14C] HRS-9190
Drug: [14C] HRS-9190
[14C] HRS-9190 for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
List of metabolites identified in plasma, urine, and feces
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events
Time Frame: up to 13 days postdose
up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
Time Frame: From 0 to 120 hours after dosing
From 0 to 120 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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