Healthy Adult MalePhase 1NCT07494175
Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants
A Phase 1 study testing [14C] HRS-9190 in people with Healthy Adult Male, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- [14C] HRS-9190
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2026to May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Male participants aged between 18 and 45 years old (inclusive);
- ASA =I;
- 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;
- 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.
Who cannot join
- Participants with a history of or current acute or chronic clinical diseases
- Participants with a history of neuromuscular diseases;
- Participants with a history of anesthetic complications;
- Participants with a history of airway diseases;
- Participants who have undergone major surgery within 6 months prior to screening;
- During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
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- 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);
- Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
- Participants with contraindications to anesthetic agents;
- 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);
- 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;
- 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;
- Participants with difficult venous access;
- Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
- Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014
About this study
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants
- Conditions
- Healthy Adult Male
- Being tested
- [14C] HRS-9190
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] HRS-9190Drug
[14C] HRS-9190 for injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: [14C] HRS-9190 | Experimental | Not described Receives: Drug: [14C] HRS-9190 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
Measured: From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma
Measured: From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose
Measured: From 0 to 120 hours after dosing
List of metabolites identified in plasma, urine, and feces
Measured: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax
Measured: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax
Measured: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2
Measured: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT
Measured: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC
Measured: From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio
Measured: From 0 to 120 hours after dosing
Secondary outcomes (2)
Adverse events
Measured: up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
Measured: From 0 to 120 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start11 Apr 2026
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494175
- Sponsor's protocol ID
- HRS-9190-103
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT07494175
- Acronym / sponsor ID
- HRS-9190-103
- Conditions
- Healthy Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: [14C] HRS-9190 | Experimental | Drug: [14C] HRS-9190 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Male participants aged between 18 and 45 years old (inclusive);
- ASA =I;
- 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;
- 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.
Key exclusion criteria (15 listed)
- Participants with a history of or current acute or chronic clinical diseases
- Participants with a history of neuromuscular diseases;
- Participants with a history of anesthetic complications;
- Participants with a history of airway diseases;
- Participants who have undergone major surgery within 6 months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] HRS-9190[14C] HRS-9190 for injection | Drug | Treatment group A: [14C] HRS-9190 |
Primary outcome
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
Time frame: 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
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
List of metabolites identified in plasma, urine, and feces
Time frame: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax
Time frame: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax
Time frame: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2
Time frame: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT
Time frame: From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC
Time frame: From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio
Time frame: From 0 to 120 hours after dosing
2 secondary outcomes
Adverse events
Time frame: up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
Time frame: From 0 to 120 hours after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] HRS-9190 in people with Healthy Adult Male, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta (time frame: From 0 to 120 hours after dosing). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.