Mass Balance Study of [14C] D-2570

NCT07411742 | Active Not Recruiting Phase 1

• 1 other identifier: D2570-104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mass Balance Study

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

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

  Baseline to 3 weeks

• Blood concentration of D-2570

  Baseline to 2 weeks

• Blood concentration of D-2570 metabolites (if applicable)

  Baseline to 2 weeks

Study Arms (1)

[14C] D-2570 group

EXPERIMENTAL

Drug: [14C] D-2570 group

Interventions

[14C] D-2570 group DRUG

\[14C\] labeled D-2570

[14C] D-2570 group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Study Officials

• Meng Wang

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 10, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)