Diseases of the cardiovascular system and immune system
Conditions
Interventions
Tianjing Mountain Project Topic I Group:NA
Tianjing Mountain Project Topic II Group:NA
Sponsors
Shaoguan First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Healthy subjects, male or female, aged 18-45 years, never smoked, with a tobacco test, in Healthy; 2. Body mass index (BMI) 19-26, male weight >= 50 kg, female weight >= 45 kg; 3. Fully understand and voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. those who have participated in any drug clinical trial within 3 months prior to the trial; 2. those who have chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding or gastrointestinal surgery within three years; 3. those with a history of cardiovascular, endocrine, urologic, neurologic, respiratory, hematologic, immunologic (including personal or family history of inherited immunodeficiency), psychiatric, or metabolic abnormalities that in the opinion of the investigator are still clinically significant at this time 4. those with a history of drug, food, or other substance allergies; 5. those with a history of tumors, epilepsy, frequent headaches, or Mycobacterium tuberculosis infection 6. Those who cannot tolerate venipuncture or have a history of blood or needle sickness; 7. those who have undergone surgery within 6 months prior to the trial that, in the judgment of the investigator, will affect the absorption, distribution, metabolism, or excretion of the drug; or those who have undergone surgery within 3 months prior to the trial; or those who plan to undergo surgery during the study period; 8. Vaccination within 3 months prior to the trial; 9. Use of any medication within 30 days prior to the trial; 10. blood donation or massive blood loss (>400 mL) within 3 months prior to the trial 11. alcoholics or regular drinkers within 6 months prior to the trial, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine); or those who are unwilling to stop consuming alcohol or to use any alcohol-containing products during the trial; or those who have a positive breath test result for alcohol (>0.0 mg/100 mL); 12. Consumption of excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) per day, or do not agree to stop drinking tea, coffee, and/or caffeinated beverages during the trial; 13. Consumption of a diet that may affect the internal metabolism of the drug (including grapefruit or grapefruit products, oranges, tangerines, strawberries, apricots, xanthine diets, etc.) within 7 days prior to administration of the study drug, or any other diet that, in the opinion of the investigator, affects the absorption, distribution, metabolism, or excretion of the drug, or does not agree to discontinue the consumption of the above diets during the trial period; 14. Those who have special dietary requirements and cannot comply with the uniform diet, or those who are lactose intolerant; 15. female subjects who have had unprotected sex within 2 weeks prior to the trial, or subjects who have a pregnancy plan, a sperm and egg donation plan within 6 months from screening to the end of the trial, or those who do not wish to use one or more non-pharmacological contraceptives (e.g., total abstinence, contraceptive rings, partner ligation, etc.) during the trial period 16 . substance abusers or those who have used soft drugs (e.g., marijuana) within 3 months prior to the trial or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to the trial; 17 . Creatinine clearance <80 mL/min {Creatinine clearance calculation Cockcroft-Gault formula: CrCl = [(140 - age) × body weight (kg)]/[0.814 × Scr (µmol/L)], creatinine clearance calculation process should be noted in the unit of creatinine; women according to the calculation results × 0.85. };
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute count of T,B,NK cell subsets;Human 70kDa heat shock protein 6;Human aquaporin 9;Oral saliva slgA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure;Heart rate;Blood routine;NK cell activity;Number of intracellular granule lysates;perforin;Granzyme A/B expression in lymphocytes;SIRPB2 signal regulatory protein ß 2;Polyclonal antibody against member B of the leukocyte immunoglobulin receptor subfamily;Human stromal cell-derived factor 1;Apolipoprotein L1; | — |
Countries
China
Contacts
Public ContactXiao Hongwei
Shaoguan First People's Hospital
Outcome results
None listed