None
Conditions
Interventions
Test Group:Subjects fasted after 21:00 on day 1 (D-1) prior to administration. At 8:00 (± 30 min) on the day of administration (D1), a single dose of Y-3 was given intravenously [14C] (with a dose of
Sponsors
First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Chinese healthy adult males, aged 18-45 years (including boundary values); 2) The body weight of the subject is not less than 50 kg, and the body mass index (BMI) is between 19.0 and 28.0 kg/m2 (including the boundary value); 3) There were no clinically significant abnormal vital signs, physical examination, laboratory examination, electrocardiogram, chest radiography and other examination results during screening/baseline period (according to the judgment of the investigator, review results were acceptable during screening period); 4) The subject (including his or her spouse or partner) has no sperm donation plan, no family planning and voluntarily adopts strict contraceptive measures (such as complete abstinence, use of condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc., as detailed in Appendix 2) during the trial period and within 1 year after the completion of the trial; 5) Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial. 1) Chinese healthy adult males, aged 18-45 years (including boundary values); 2) The body weight of the subject is not less than 50 kg, and the body mass index (BMI) is between 19.0 and 28.0 kg/m2 (including the boundary value); 3) There were no clinically significant abnormal vital signs, physical examination, laboratory examination, electrocardiogram, chest radiography and other examination results during screening/baseline period (according to the judgment of the investigator, review results were acceptable during screening period); 4) The subject (including his or her spouse or partner) has no sperm donation plan, no family planning and voluntarily adopts strict contraceptive measures (such as complete abstinence, use of condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc., as detailed in Appendix 2) during the trial period and within 1 year after the completion of the trial; 5) Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) Allergy, such as a known history of allergy to two or more substances, or allergic diseases, or a history of allergy to the test drug or similar drugs or excipients (polyethylene glycol 15-hydroxystearate, propylene glycol, potassium dihydrogen phosphate, dipotassium diphosphate trihydrate, mannitol); 2) Have a history of clinically serious diseases or diseases or conditions that the investigator believes may affect the test results, including but not limited to digestive system, circulatory system, respiratory system, endocrine and metabolic system, nervous system, urinary system, or history of blood, immune, psychiatric and metabolic diseases; Or because of neurological, mental illness or language disorders, or other inability to communicate with medical personnel or collaborators; 3) A history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsional ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and a family history (as shown by genetic evidence or a close relative's sudden death due to cardiac causes at a young age); 4) Major surgery or surgical incision not fully healed within 6 months before screening; Major surgery includes, but is not limited to, any surgery where there is a significant risk of bleeding, extended period of general anesthesia, or open biopsy or significant traumatic injury; 5) Human immunodeficiency virus antibody test positive, treponema pallidum specific antibody test positive, hepatitis B surface antigen test positive or hepatitis C antibody test positive; 6) Have taken any prescription or over-the-counter drugs, Chinese or Chinese herbs, health products, or have received vaccination within 14 days prior to screening; Or those who plan to be vaccinated during the trial; 7) Those who have taken any clinical trial drug or participated in any other clinical trial (including drug and device clinical trials) within 3 months prior to the screening period; 8) Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; 9) Hemorrhoids, or screening/baseline fecal occult blood test positive; 10) Those who have lost blood or donated blood (=400 mL) within 3 months before screening, or received blood transfusion or blood components within 1 month, or plan to donate blood within 3 months after the end of this trial; 11) Smokers who smoked more than 5 cigarettes per day or habitually-used nicotine-containing products in the 3 months before the screening period and could not quit during the trial; 12) Current or past alcohol abuse or regular drinking in the six months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or a positive alcohol breath test (alcohol breath test result >0 mg/100 mL), Or unable to abstain during the trial; 13) Drug abuse or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, amphetamines, PCP, etc.) in the year prior to screening, or positive urine drug abuse screening (morphine, THC, methamphetamine, dimethylene dioxyamphetamine, ketamine); 14) Habitual or excessive (more than 8 cups a day, 1 cup =250 mL) consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, and unable to abstain during the trial period; 15) Those who have special requirements for diet and cannot comply with a unified diet; 16) have participated in clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-8;t1/2;MRT0-t;MRT0-8;Cumulative drug excretion;The proportion of active drugs and metabolites; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-8;t1/2;MRT0-t;MRT0-8;physical examination;vital signs monitoring;blood routine;blood biochemistry;urine routine;coagulation function;stool for routine;ECG;adverse event;clinical symptom; | — |
Countries
China
Contacts
Public ContactLiu Yun
First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed