None
Conditions
Interventions
Experimental Group:Participants fasted for at least 10 h before administration, and took [14C] CMS-D001 suspension containing about 200 mg/ 100 µ CI on an empty stomach in the morning of the day of Ad
Sponsors
Beijing Gaobo Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. participants must be fully informed of the test, understand and understand the test content, process and possible adverse events related to the test drug before the test, and voluntarily sign a written informed consent; 2. Chinese adult male participants aged 18-55 years (including boundary value); 3. at the time of screening, the weight of the participants was not less than 50 kg, and the body mass index (BMI) was in the range of 19.0-26.0 kg/m^2 (including the boundary value); 4. the participants did not have a sperm donation plan within 6 months after administration, and the participants and their partners did not have a pregnancy plan during the study period and within 6 months after administration and voluntarily took effective contraceptive measures to avoid pregnancy of the participants' partners
Exclusion criteria
Exclusion criteria: The researchers determined that there were other diseases or medical histories of clinical significance or that might 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, blood system, immune system, mental system, endocrine and metabolic system, etc. 2. Screen for a history of depression or post-traumatic stress disorder within the two years prior to the visit; Or has had suicidal behavior or suicidal tendencies; Or, as determined by the researcher to have suicidal tendencies, it may increase the risk of participating in the study, and based on the researcher's judgment, it is not suitable to participate in the study; 3. Have suffered from severe infectious diseases within 6 months prior to screening, or have a history of chronic or recurrent infectious diseases; 4. At the time of screening or baseline, there was or was a history of tuberculosis (TB) disease and exposure, or other pulmonary infectious diseases; 5. Those who have had symptomatic herpes zoster or herpes simplex within 3 months prior to screening; 6. Having a history of infection and/or fever within 7 days prior to screening; 7. Had a history of lymphoid tissue hyperplasia disease; 8. A first-degree relative has a hereditary immune deficiency disease; 9. There is a history of venous thromboembolism (VTE) or coagulation dysfunction in the past; 10. Those who have abnormalities in vital signs examination, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (upright), abdominal B-ultrasound, etc. at the time of screening or baseline and are judged by the researcher to have clinical significance; 11. During the screening period or baseline period, if the 12-lead electrocardiogram has the following results: QTcF>=450 ms; Or those with abnormal electrocardiogram indicators and clinical significance; 12. Any one of the results of quantitative determination of hepatitis B surface antigen, determination of hepatitis C antibody, determination of Treponema pallidum antibody or determination of human immunodeficiency virus antigen-antibody is positive; 13. Any surgical procedures that may affect drug metabolism and excretion (such as cholecystectomy, except for appendicitis surgery); Or those who plan to undergo surgery during the trial period; 14. Those with hemorrhoids accompanied by hematochezia or those with regular or ongoing hematochezia due to perianal diseases; Or there was severe nausea or vomiting within one week before screening; Or those with habitual constipation or diarrhea; Or those with a positive fecal occult blood test; 15. Any prescription drugs, over-the-counter drugs, Chinese herbal medicines, food supplements (including vitamins, health foods, etc.) have been used within 14 days before administration, or there are other non-drug treatment factors that affect drug absorption, distribution, metabolism, and excretion; Having used drugs or substances known as CYP3A4 inducers or inhibitors within one month before baseline; 16. Have a history of drug allergy or allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.), or be determined by the researcher to be possibly or clearly allergic to the investigational drug (including similar drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total radioactivity recovery and cumulative total radioactivity recovery at each time interval in excreta (urine and feces);Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable): Cmax, Tmax, t1/2, MRT, AUC, etc; Ratio of total radioactivity concentration in whole blood and plasma, etc;The percentage of plasma protodrugs and their metabolites (if applicable) in the total plasma radiation exposure; Urinary and fecal protodrugs and their metabolites (if applicable) as a percentage of the administered dose (%dose); Identification of major metabolites in plasma, urine and feces; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of CMS-D001, M414-2 and their main metabolites (if applicable) in plasma: Cmax, Tmax, t1/2, MRT, AUC, etc;The incidence of adverse events (AE), serious adverse events (SAE), and clinically significant abnormal value safety evaluation indicators (including but not limited to: physical examination, vital signs, 12 lead ECG, clinical laboratory tests, etc.) were analyzed and summarized; | — |
Countries
China
Contacts
Public ContactZhuang Quankun;Liu Xuemei
Beijing Gaobo Hospital
Outcome results
None listed