Study on the Mass Balance of [14C] CMS-D002 in Healthy Adult Participants in China

NCT07788482 | Not Yet Recruiting Phase 1

• 1 other identifier: D002-01-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1, single-group study will evaluate the mass balance of \[14C\] CMS-D002 after a single oral dose in healthy adult participants in China. The study will assess total radioactivity recovery and routes of excretion, characterize whole-blood and plasma pharmacokinetics, and determine metabolite profiles and major biotransformation pathways.

Conditions

Healthy Volunteers

Keywords

Mass Balance

Outcome Measures

Primary Outcomes (7)

• Total radioactivity recovery and cumulative total radioactivity recovery at each time interval in excreta (urine and feces).

  Day 16

• Percentage of parent drug and metabolites in total plasma radioactivity exposure and in the administered dose recovered in urine and feces (%Dose).

  Day 16

• Tmax (time to maximum observed concentration) parameters of total radioactivity

  Day 16

• t1/2 (terminal elimination half-life) parameters of total radioactivity

  Day 16

• Cmax (maximum concentration) parameters of total radioactivity

  Day 16

• MRT (mean residence time) parameters of total radioactivity

  Day 16

• AUC (area under curve) parameters of total radioactivity

  Day 16

Secondary Outcomes (7)

• Incidence of adverse events (AE) and serious adverse events (SAE), and analysis and summary of clinically significant abnormal safety evaluation indicators.

  Day 16

• Tmax parameters of CMS-D002 and its metabolites

  Day 16

• Cmax parameters of CMS-D002 and its metabolites

  Day 16

• AUC0-t parameters of CMS-D002 and its metabolites

  Day 16

• T1/2 parameters of CMS-D002 and its metabolites

  Day 16

Study Arms (1)

Experimental Group

EXPERIMENTAL

Healthy adult participants will receive a single oral dose of \[14C\] CMS-D002.

Drug: [14C] CMS-D002

Interventions

[14C] CMS-D002 DRUG

Single oral dose administration of \[14C\] CMS-D002.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Participants must be fully informed about the trial prior to participation, understand the trial content, procedures, and possible adverse events related to the investigational drug, and voluntarily sign a written informed consent form;
• Chinese adult participants aged 18-45 years (inclusive);
• At screening, male participants weigh no less than 50 kg, female participants weigh no less than 45 kg, and body mass index \[BMI = weight (kg) / height² (m²)\] ranges from 19.0-26.0 kg/m² (inclusive);
• Female participants have a regular menstrual history, with at least two consecutive regular menstrual cycles (21-35 days, inclusive) in the most recent period prior to screening, and no abnormal uterine bleeding;
• Participants of childbearing potential voluntarily adopt highly effective contraception from signing informed consent until 6 months after trial completion (see Appendix I for details; female participants prohibited from using oral contraceptives during the study), and have no plans for oocyte or sperm cryopreservation or donation during this period.

You may not qualify if:

• Investigator determines the presence of other clinically significant diseases or medical histories that may prevent participants from following the research protocol and completing this study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, immune system, psychiatric system, endocrine and metabolic system, etc.;
• Currently or previously diagnosed with osteoporosis or other metabolic bone diseases;
• Severe infectious diseases (requiring hospitalization, parenteral antibiotic treatment, or opportunistic infections) within 6 months prior to screening, or history of chronic or recurrent infectious diseases;
• History of infection and/or fever within 7 days prior to screening;
• Abnormalities in vital signs examination, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), chest X-ray (upright), abdominal B-ultrasound, sex hormone tests, breast, uterus and adnexa B-ultrasound (females), reproductive system and urinary system color Doppler ultrasound (males), etc., at screening or baseline, deemed clinically significant by the investigator; or alanine aminotransferase or aspartate aminotransferase exceeding 1.2 times the upper limit of normal (ULN) at screening or baseline;
• lead ECG at screening or baseline showing: QTcF ≥450 ms (males), QTcF ≥460 ms (females); or other ECG abnormalities deemed clinically significant;
• Positive results in any of hepatitis B surface antigen quantitative test, hepatitis C antibody test, Treponema pallidum antibody test, or human immunodeficiency virus antigen-antibody test;
• Any surgical procedures that may affect drug metabolism and excretion (e.g., cholecystectomy, except appendectomy); or planned surgery during the trial period;
• Hemorrhoids with hematochezia or perianal diseases with periodic/ongoing hematochezia; or severe nausea or vomiting within one week prior to screening; or habitual constipation or diarrhea; or positive fecal occult blood test;
• Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, food supplements (including vitamins, health foods, etc.) within 14 days prior to administration, or presence of other non-drug treatment factors affecting drug absorption, distribution, metabolism, and excretion; use of known CYP3A4 inducers or inhibitors within 1 month prior to baseline (see Appendix II);
• History of drug allergy or allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or deemed possibly or definitely allergic to the investigational drug (including similar drugs) or any of its excipients by the investigator;
• Received any other investigational drugs or participated in any interventional clinical studies within 3 months or 5 half-lives (whichever is longer) prior to screening;
• Blood donation or blood loss ≥400 mL within 3 months prior to administration, or blood transfusion or use of blood products within 4 weeks prior to administration;
• Difficulty in blood collection or intolerance to venipuncture;
• Workers requiring long-term exposure to radioactive conditions, or significant radioactive exposure within 1 year prior to screening (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations), or participation in radiolabeled drug trials within 1 year prior to screening;

Sponsors & Collaborators

• Shenzhen Kangzhe Biotechnology Co., Ltd.: lead

Study Sites (1)

Beijing Gaobo Hospital

Beijing, Beijing Municipality, 102200, China

Location

Central Study Contacts

Xianping Rao

CONTACT

+86 755 8241 8801; raoxianping@cms.net.cn

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: August 11, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)