Type 2 Diabetes MellitusPhase 1NCT06855147
Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects
A Phase 1 study testing [14C]HRS9531 in people with Type 2 Diabetes Mellitus and Weight Loss, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Weight Loss
- What is being tested?
- [14C]HRS9531
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 17 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
- Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
- Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
- 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.
Who cannot join
- History of any clinically important disease or disorder.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus, Weight Loss
- Being tested
- [14C]HRS9531
- Medical subject headings
- Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]HRS9531Drug
A single dose of [14C]HRS9531 injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| [14C]HRS9531 Group | Experimental | Not described Receives: Drug: [14C]HRS9531 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax).
Measured: 0 to anticipated 64 days.
Time to reach the maximum concentration (Tmax).
Measured: 0 to anticipated 64 days.
Half-life (t1/2).
Measured: 0 to anticipated 64 days.
Total radioactive recovery rate in urine.
Measured: 0 to anticipated 64 days.
Total radioactive recovery rate in feces.
Measured: 0 to anticipated 64 days.
Cumulative radioactive recovery rate in urine.
Measured: 0 to anticipated 64 days.
Cumulative radioactive recovery rate in feces.
Measured: 0 to anticipated 64 days.
Secondary outcomes (4)
Whole blood total radioactivity (TRA) ratio.
Measured: 0 to anticipated 64 days.
Plasma total radioactivity (TRA) ratio.
Measured: 0 to anticipated 64 days.
Adverse events (AEs).
Measured: 0 to 7 days after the last sample collection.
Serious adverse events (SAEs).
Measured: 0 to 7 days after the last sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start21 Apr 2025
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855147
- Sponsor's protocol ID
- HRS9531-109
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2025
- Last updated
- 4 Jul 2025
- 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Phase Ⅰ Clinical Study of the Absorption, Metabolism, and Excretion of [14C]HRS9531 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06855147
- Acronym / sponsor ID
- HRS9531-109
- Conditions
- Type 2 Diabetes Mellitus, Weight Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 3 Mar 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]HRS9531 Group | Experimental | Drug: [14C]HRS9531 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
- Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
- Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
- 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.
Key exclusion criteria (4 listed)
- History of any clinically important disease or disorder.
- 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.
- 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.
- 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.
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]HRS9531A single dose of [14C]HRS9531 injected subcutaneously. | Drug | [14C]HRS9531 Group |
Primary outcome
Maximum concentration (Cmax).
Time frame: 0 to anticipated 64 days.
Time to reach the maximum concentration (Tmax).
Time frame: 0 to anticipated 64 days.
Half-life (t1/2).
Time frame: 0 to anticipated 64 days.
Total radioactive recovery rate in urine.
Time frame: 0 to anticipated 64 days.
Total radioactive recovery rate in feces.
Time frame: 0 to anticipated 64 days.
Cumulative radioactive recovery rate in urine.
Time frame: 0 to anticipated 64 days.
Cumulative radioactive recovery rate in feces.
Time frame: 0 to anticipated 64 days.
4 secondary outcomes
Whole blood total radioactivity (TRA) ratio.
Time frame: 0 to anticipated 64 days.
Plasma total radioactivity (TRA) ratio.
Time frame: 0 to anticipated 64 days.
Adverse events (AEs).
Time frame: 0 to 7 days after the last sample collection.
Serious adverse events (SAEs).
Time frame: 0 to 7 days after the last sample collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- 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]HRS9531 in people with Type 2 Diabetes Mellitus and Weight Loss, run by Fujian Shengdi Pharmaceutical 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum concentration (Cmax). (time frame: 0 to anticipated 64 days.). The study lists 7 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 4 Jul 2025.