Type 2 Diabetes MellitusPhase 1NCT06819488
A Clinical Study of Mass Balance of [14C]HRS-7535
A Phase 1 study testing [14C]HRS-7535 in people with Type 2 Diabetes Mellitus and Weight Loss, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects. 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
- Type 2 Diabetes Mellitus, Weight Loss
- What is being tested?
- [14C]HRS-7535
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 16 Apr 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must voluntarily sign the informed consent form (ICF) prior to any activities related to the study, demonstrate understanding of the study procedures and methods, and commit to strictly adhering to the clinical trial protocol to complete the study.
- Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.
- Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).
- Male subjects with female partners of childbearing potential must have no plans for procreation or sperm donation from the time of signing the informed consent until one year after the last dose of the study drug. They must also agree to use highly effective contraception methods (including their partners) during this period.
Who cannot join
- Subjects with abnormalities identified through a comprehensive physical examination, vital signs assessment, laboratory tests, chest X-ray, 12-lead ECG, or abdominal ultrasound that are deemed clinically significant by the investigator.
- Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.
- Subjects who test positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antigen/antibody combination, or syphilis-specific antibodies.
- Subjects with a history of drug abuse, drug dependence (based on medical history), or those who test positive for drug abuse during urine screening prior to dosing.
- Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects
The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects.
- Conditions
- Type 2 Diabetes Mellitus, Weight Loss
- Being tested
- [14C]HRS-7535
- 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]HRS-7535Drug
[14C]HRS-7535.
| Study group | Role | What they receive |
|---|---|---|
| [14C]HRS-7535 | Experimental | Not described Receives: Drug: [14C]HRS-7535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of maximum observed concentration (Tmax)
Measured: 0-120 hours.
The maximum observed concentration (Cmax)
Measured: 0-120 hours.
The terminal half-life (t1/2)
Measured: 0-120 hours.
The total body clearance for extravascular administration (CL/F)
Measured: 0-120 hours.
The total radioactivity ratio for blood
Measured: 0-96 hours.
The total radioactivity ratio for plasma
Measured: 0-96 hours.
Secondary outcomes (2)
Adverse events (AEs)
Measured: 0-11 days.
Serious adverse events (AEs)
Measured: 0-11 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start27 Feb 2025
- Primary completion16 Apr 2025
- Study completion16 Apr 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 Shandong Suncadia 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
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819488
- Sponsor's protocol ID
- HRS-7535-106
- Status last verified
- May 2025
- First submitted
- 5 Feb 2025
- Last updated
- 7 May 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT06819488
- Acronym / sponsor ID
- HRS-7535-106
- Conditions
- Type 2 Diabetes Mellitus, Weight Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 11 Feb 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.
The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]HRS-7535 | Experimental | Drug: [14C]HRS-7535 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects must voluntarily sign the informed consent form (ICF) prior to any activities related to the study, demonstrate understanding of the study procedures and methods, and commit to strictly adhering to the clinical trial protocol to complete the study.
- Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.
- Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).
- Male subjects with female partners of childbearing potential must have no plans for procreation or sperm donation from the time of signing the informed consent until one year after the last dose of the study drug. They must also agree to use highly effective contraception methods (including their partners) during this period.
Key exclusion criteria (5 listed)
- Subjects with abnormalities identified through a comprehensive physical examination, vital signs assessment, laboratory tests, chest X-ray, 12-lead ECG, or abdominal ultrasound that are deemed clinically significant by the investigator.
- Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.
- Subjects who test positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antigen/antibody combination, or syphilis-specific antibodies.
- Subjects with a history of drug abuse, drug dependence (based on medical history), or those who test positive for drug abuse during urine screening prior to dosing.
- Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks 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-7535[14C]HRS-7535. | Drug | [14C]HRS-7535 |
Primary outcome
The time of maximum observed concentration (Tmax)
Time frame: 0-120 hours.
The maximum observed concentration (Cmax)
Time frame: 0-120 hours.
The terminal half-life (t1/2)
Time frame: 0-120 hours.
The total body clearance for extravascular administration (CL/F)
Time frame: 0-120 hours.
The total radioactivity ratio for blood
Time frame: 0-96 hours.
The total radioactivity ratio for plasma
Time frame: 0-96 hours.
2 secondary outcomes
Adverse events (AEs)
Time frame: 0-11 days.
Serious adverse events (AEs)
Time frame: 0-11 days.
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 7 May 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]HRS-7535 in people with Type 2 Diabetes Mellitus and Weight Loss, run by Shandong Suncadia 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 4 inclusion and 5 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 7 May 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?
The time of maximum observed concentration (Tmax) (time frame: 0-120 hours.). The study lists 6 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 7 May 2025.