Mass Balance Study of [14C] D-2570

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mass Balance Study
• Intervention / Treatment: Drug: [14C] D-2570 group

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] D-2570 group	Drug: [14C] D-2570 group; [14C] labeled D-2570

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Principal Investigator: Meng Wang, Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D2570-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No