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Healthy VolunteersPhase 1NCT07788482

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

A Phase 1 study testing [14C] CMS-D002 in people with Healthy Volunteers, run by Shenzhen Kangzhe Biotechnology Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[14C] CMS-D002
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
Sep 2026to Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • 12-lead ECG at screening or baseline showing: QTcF ≥450 ms (males), QTcF ≥460 ms (females); or other ECG abnormalities deemed clinically significant;
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  • 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;
  • History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine);
  • Average alcohol consumption ≥14 units per week in the 3 months prior to screening (1 unit ≈ 360 mL beer, 45 mL spirits, or 150 mL wine), or positive alcohol breath test;
  • Average daily cigarette smoking >5 cigarettes (or equivalent nicotine products) in the 3 months prior to administration, or unable to abstain from any tobacco products during the trial;
  • Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages (>8 cups/day, 1 cup = 250 mL), and unable to abstain during the trial; or intake of any chocolate-, caffeine-, or xanthine-rich foods or beverages within 48 hours prior to administration;
  • Vaccination within 4 weeks prior to administration, or planned vaccination within 1 month after administration;
  • Female participants with history of pregnancy, abortion, delivery, or lactation within 6 months prior to screening, or currently pregnant or lactating, or positive serum pregnancy test;
  • Use of oral contraceptives within 30 days prior to screening, or oral contraceptives still within efficacy period at the time of study drug administration (applicable only to female participants);
  • Women of childbearing potential who engaged in unprotected sex with partners within 14 days prior to screening;
  • Use of long-acting estrogen or progestin injections or implants within 6 months prior to screening, or such injections/implants still within efficacy period at the time of study drug administration (applicable only to female participants);
  • Other reasons deemed by the investigator as making the participant unsuitable for this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianping Rao contact

+86 755 8241 8801

raoxianping@cms.net.cn

China1 site

  • Beijing Gaobo Hospital

    Beijing, Beijing Municipality, 102200

    Quankun Zhuang, 86 10 5084 7588, quankun.zhuang@gobroadaro.com

    Xuemei Liu, 86 10 5084 7588, liuxm@gobroadhealthcare.com

Other trials in China

About this study

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.

Being tested
[14C] CMS-D002
Keywords
Mass Balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C] CMS-D002Drug

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

Study groups in NCT07788482
Study groupRoleWhat they receive
Experimental GroupExperimentalHealthy adult participants will receive a single oral dose of [14C] CMS-D002.
Receives: Drug: [14C] CMS-D002

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 16

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

    Measured: Day 16

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

    Measured: Day 16

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

    Measured: Day 16

  5. Cmax (maximum concentration) parameters of total radioactivity

    Measured: Day 16

  6. MRT (mean residence time) parameters of total radioactivity

    Measured: Day 16

  7. AUC (area under curve) parameters of total radioactivity

    Measured: Day 16

Secondary outcomes (7)

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

    Measured: Day 16

  2. Tmax parameters of CMS-D002 and its metabolites

    Measured: Day 16

  3. Cmax parameters of CMS-D002 and its metabolites

    Measured: Day 16

  4. AUC0-t parameters of CMS-D002 and its metabolites

    Measured: Day 16

  5. T1/2 parameters of CMS-D002 and its metabolites

    Measured: Day 16

  6. MRT parameters of CMS-D002 and its metabolites

    Measured: Day 16

  7. AUC parameters of CMS-D002 and its metabolites

    Measured: Day 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07788482
Sponsor's protocol ID
D002-01-002
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect the privacy and confidentiality of study participants, in accordance with ethical guidelines and regulatory requirements, individual participant data (IPD) will not be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] CMS-D002 in people with Healthy Volunteers, run by Shenzhen Kangzhe Biotechnology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianping Rao (+86 755 8241 8801, raoxianping@cms.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total radioactivity recovery and cumulative total radioactivity recovery at each time interval in excreta (urine and feces). (time frame: Day 16). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07788482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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