Secondary hyperparathyroidism
Conditions
Interventions
Experimental group:Injection of SHR6508
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female aged 18-45 years (including the boundary value); 2. Male subjects weighing >=50.0 kg, female subjects weighing >=45.0 kg, and a body mass index (BMI) between 19.0-26.0 kg/m^2 (including boundary values), (BMI=weight(kg)/height2(m^2)); 3. The subject promises to have no fertility, sperm or egg donation plan during the trial period and within 3 months after the last medication and voluntarily take effective physical contraception (including partners); 4. Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial before the trial, and voluntarily participate in this clinical trial, able to communicate well with investigators, comply with the requirements of the entire study, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with a history of drug allergy, or a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to two or more drugs, food and pollen) or known allergy to the components or analogs of this medicine; 2. Past medical history or current clinically clear heart, respiratory, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, nervous system diseases or mental illness, metabolic abnormality/function disorder, benign parathyroid tumor, etc.; 3. Those with a history of active pathological bleeding (such as peptic ulcer, intracranial hemorrhage, etc.), or those with bleeding tendency (such as coagulation dysfunction, repeated gingival bleeding, etc.); 4. The test results of parathyroid hormone level and blood electrolyte level (such as serum sodium, serum potassium, serum chloride, serum calcium, serum phosphorus) during the screening period are abnormal; 5. During the screening period of the test, the HIV test was positive or/and the hepatitis B surface antigen, hepatitis C, syphilis serotonin was positive; 6. Those who have undergone major surgery within 3 months before the trial, or those who have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug; 7. Those who used other clinical trial drugs within 3 months before the trial or planned to participate in other clinical trials during this study; 8. Those who have used or are using any drugs within 2 weeks before the test, including vitamins and Chinese herbal medicines; 9. Those who lost blood or donated more than 200 ml of blood within 3 months before this clinical trial (excluding women's menstrual blood loss), or intended to donate blood during the trial or within 1 month after the end of the trial; 10. Have taken a special diet (including grapefruit and/or xanthine diet, chocolate) and/or consumed excessive daily tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages within 2 weeks prior to dosing ( An average of more than 8 cups per day, 200 mL per cup); 11. Those who smoked more than 5 cigarettes on average per day in the 3 months before screening, or who did not agree to ban smoking during the trial; 12. Drink more than 14 units of alcohol per week on average in the 3 months prior to screening (1 unit = 360 mL of beer with 5% alcohol or 45 mL of spirits with 40% alcohol or 150 mL of wine with 12% alcohol ), or those who do not agree to abstain from alcohol during the trial; 13. Those who have taken special diets (including grapefruit, grapefruit, chocolate, coffee, and strong tea) within 48 hours before receiving the study drug for the first time, or those who do not agree to prohibit the intake of the above diets during the trial; 14. Patients who are pregnant or breastfeeding or those with clinically significant pregnancy test results; 15. Those with a history of drug abuse or drug abuse or those with positive urine drug screening; 16. Positive alcohol breath test; 17. Those who have special requirements for diet and cannot comply with the unified diet; 18. Those who cannot tolerate intravenous injection, venipuncture or have a history of fainting and bleeding; 19. Those who have received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening, or plan to receive inactivated/live/attenuated vaccine during the trial; 20. The inv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital, Central South University
Outcome results
None listed