Mass Balance StudyPhase 1NCT07411742
Mass Balance Study of [14C] D-2570
A Phase 1 study testing [14C] D-2570 group in people with Mass Balance Study, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated… 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
- Mass Balance Study
- What is being tested?
- [14C] D-2570 group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 31 Aug 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 subject must voluntarily participates in this study after full informed consent.
- Chinese male healthy subjects aged 18-45 years (inclusive) at the time of signing the ICF
- At screening, subject's body weight is ≥50.0 kg, with a body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive)
- Subjects have no plans for reproduction or sperm donation during the trial and for 6 months after study drug administration. Subjects agree to practice complete abstinence, have undergone sterilization surgery, or agree to use effective contraception from the time of ICF signing throughout the entire study period until 6 months after study drug administration.
Who cannot join
- Findings from screening assessments judged by the investigator as abnormal and clinically significant
- History of infection as defined in the protocol.
- Any of the medical diseases or disorders listed in the protocol.
- Unable to comply with the lifestyle restrictions stipulated in the protocol.
- Medication history does not meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
About this study
Official title: Mass Balance Study of [14C] D-2570 in Chinese Healthy Adult Male Subjects
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows:
To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.
- Conditions
- Mass Balance Study
- Being tested
- [14C] D-2570 group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] D-2570 groupDrug
[14C] labeled D-2570
| Study group | Role | What they receive |
|---|---|---|
| [14C] D-2570 group | Experimental | Not described Receives: Drug: [14C] D-2570 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
Measured: 2 weeks
Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)
Measured: 2 weeks
Total Radioactivity of D-2570 in Plasma and Whole Blood
Measured: baseline to 2 weeks
Whole blood/plasma ratio for TRA (total radioactivity) at different time points
Measured: Baseline to 2 weeks
Secondary outcomes (3)
Incidence and severity of AEs based on NCI CTCAE V6.0
Measured: Baseline to 3 weeks
Blood concentration of D-2570
Measured: Baseline to 2 weeks
Blood concentration of D-2570 metabolites (if applicable)
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Mar 2026
- Primary completion31 Mar 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass Balance StudyStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meng Wang, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411742
- Sponsor's protocol ID
- D2570-104
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C] D-2570 in Chinese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07411742
- Acronym / sponsor ID
- D2570-104
- Conditions
- Mass Balance Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 17 Feb 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.
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows:
To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] D-2570 group | Experimental | Drug: [14C] D-2570 group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject must voluntarily participates in this study after full informed consent.
- Chinese male healthy subjects aged 18-45 years (inclusive) at the time of signing the ICF
- At screening, subject's body weight is ≥50.0 kg, with a body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive)
- Subjects have no plans for reproduction or sperm donation during the trial and for 6 months after study drug administration. Subjects agree to practice complete abstinence, have undergone sterilization surgery, or agree to use effective contraception from the time of ICF signing throughout the entire study period until 6 months after study drug administration.
Key exclusion criteria (5 listed)
- Findings from screening assessments judged by the investigator as abnormal and clinically significant
- History of infection as defined in the protocol.
- Any of the medical diseases or disorders listed in the protocol.
- Unable to comply with the lifestyle restrictions stipulated in the protocol.
- Medication history does not meet the requirements of the protocol.
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] D-2570 group[14C] labeled D-2570 | Drug | [14C] D-2570 group |
Primary outcome
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
Time frame: 2 weeks
Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)
Time frame: 2 weeks
Total Radioactivity of D-2570 in Plasma and Whole Blood
Time frame: baseline to 2 weeks
Whole blood/plasma ratio for TRA (total radioactivity) at different time points
Time frame: Baseline to 2 weeks
3 secondary outcomes
Incidence and severity of AEs based on NCI CTCAE V6.0
Time frame: Baseline to 3 weeks
Blood concentration of D-2570
Time frame: Baseline to 2 weeks
Blood concentration of D-2570 metabolites (if applicable)
Time frame: Baseline to 2 weeks
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Meng Wang principal investigator
Second Affiliated Hospital of Soochow University
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] D-2570 group in people with Mass Balance Study, run by InventisBio 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: under way, not looking for participants, as of the sponsor's last update on 29 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?
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose (time frame: 2 weeks). The study lists 4 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 29 Apr 2026.