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Clinical Trials in China / NCT07411742
Active, not recruiting Phase 1

Mass Balance Study of [14C] D-2570

NCT07411742 · tracked via the Priya Life Science China tracker
Sponsor
InventisBio Co., Ltd
Phase
Phase 1
Started
2026-03-10
Last updated
2026-04-29

Condition(s) studied

Mass Balance Study

Investigational drug(s) / intervention(s)

[14C] D-2570 group

[14C] D-2570 group: \[14C\] labeled D-2570

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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: * 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.

Primary outcome measure(s)

  • Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose — 2 weeks
  • Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug) — 2 weeks
  • Total Radioactivity of D-2570 in Plasma and Whole Blood — baseline to 2 weeks
  • Whole blood/plasma ratio for TRA (total radioactivity) at different time points — Baseline to 2 weeks

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu

More InventisBio Co., Ltd trials in China

Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis Recruiting
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function Recruiting
The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function. Recruiting
A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis Recruiting
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07411742 on ClinicalTrials.gov ↗ ← All trials in China