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Active, not recruitingNCT07411742Updated Apr 29, 2026

Mass Balance Study of [14C] D-2570

A Phase 1 interventional study of [14C] D-2570 group in Mass Balance Study, sponsored by InventisBio Co., Ltd. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by InventisBio Co., Ltd · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Mass Balance Study
03

In context

Lead sponsor

InventisBio Co., Ltd is the lead sponsor of 32 studies on the registry; 10 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    [14C] D-2570 group

    Drug: [14C] D-2570 group

Interventions

  • Drug[14C] D-2570 group

    \[14C\] labeled D-2570

06

What researchers measure

Primary outcomes

  1. Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose

    Time frame: 2 weeks

  2. Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)

    Time frame: 2 weeks

  3. Total Radioactivity of D-2570 in Plasma and Whole Blood

    Time frame: baseline to 2 weeks

  4. Whole blood/plasma ratio for TRA (total radioactivity) at different time points

    Time frame: Baseline to 2 weeks

Secondary outcomes

  1. Incidence and severity of AEs based on NCI CTCAE V6.0

    Time frame: Baseline to 3 weeks

  2. Blood concentration of D-2570

    Time frame: Baseline to 2 weeks

  3. Blood concentration of D-2570 metabolites (if applicable)

    Time frame: Baseline to 2 weeks

07

Study locations

1 site
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07411742
Lead sponsor
InventisBio Co., Ltd
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 10, 2026
Primary completion
Mar 31, 2026
Completion
Aug 31, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Meng Wang
principal investigator · Second Affiliated Hospital of Soochow University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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