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.
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;
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;
Single group
[14C] CMS-D002
DrugSingle oral dose administration of \[14C\] CMS-D002.
Total radioactivity recovery and cumulative total radioactivity recovery at each time interval in excreta (urine and feces).
Percentage of parent drug and metabolites in total plasma radioactivity exposure and in the administered dose recovered in urine and feces (%Dose).
Tmax (time to maximum observed concentration) parameters of total radioactivity
t1/2 (terminal elimination half-life) parameters of total radioactivity
Incidence of adverse events (AE) and serious adverse events (SAE), and analysis and summary of clinically significant abnormal safety evaluation indicators.
Tmax parameters of CMS-D002 and its metabolites
Cmax parameters of CMS-D002 and its metabolites
AUC0-t parameters of CMS-D002 and its metabolites
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