Secondary hyperparathyroidism in patients with chronic kidney disease
Conditions
Interventions
Group 1:MT1013 for Injection
Group 2:Placebo
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Gender: Chinese healthy male or female subjects with appropriate gender ratio; 2. Age: 18~45 years old (including the boundary value); 3. Body weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and the body mass index [BMI=weight (kg)/height 2 (m^2)] is 19.0~26.0kg/ Within the range of m^2 (including boundary values); 4. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent; 5. The subject can communicate well with the researcher.
Exclusion criteria
Exclusion criteria: 1. Past history of drug allergy (especially known or suspected allergic history to any calcium-sensing receptor agonist drugs or their auxiliary components) or history of atopic allergic diseases (asthma, urticaria, eczema) dermatitis) or severe allergic constitution, or allergic to MT1013 for injection and any ingredients in excipients; 2. Those who cannot comply with a unified diet (such as intolerance to standard meals, etc.); 3. Those who cannot tolerate venipuncture, those who have a history of fainting with needles and blood; 4. Patients with a history of clinically significant abnormal electrocardiogram or QT interval prolongation syndrome, and a history of epileptic seizures in the past; 5. Those who have undergone major surgery (except appendicitis surgery) within 6 months before screening; 6. Hepatitis B surface antigen positive, or hepatitis C virus antibody positive, or HIV antibody positive, or Treponema pallidum antibody positive; 7. Pregnant or lactating women, or subjects (or their partners) who plan to become pregnant during the study or within 6 months after the end of the study; 8. Those who have used long-acting estrogen or progesterone injections or implants within 6 months before the study administration; those who have used short-acting contraceptives within 30 days before the study administration; 9. Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines, and health products within 14 days before the study administration; 10. Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 200mL) within 3 months before screening; or within 48 hours before study administration, ingest any caffeinated food or Beverages (such as coffee, strong tea, chocolate, etc.); 11. Within 48 hours before the study administration, ingested any beverage or food rich in xanthine or grapefruit ingredients or quinine or other influences on drug absorption, distribution, metabolism, excretion, etc. (including any grapefruit fruit or containing food or drink containing grapefruit); 12. Ex-smokers (that is, using tobacco or nicotine products within 3 months before screening), or those with positive smoke tests, or those who cannot accept non-smoking throughout the trial period; 13. Drink more than 14 standard units per week within 6 months before screening (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with 40% alcohol content or 150mL wine), or those who have a positive result of alcohol urine screening and Those who are prohibited from drinking alcohol after enrollment and throughout the trial period cannot be accepted; 14. Those with a history of drug abuse (such as ketamine, morphine, cocaine, methamphetamine, MDMA, THC) within 1 year before screening, or drug abuse urine screening The test result is positive; 15. Participated in other clinical trials within 3 months before screening; 16. Those who donated blood or lost blood >=360mL within 3 months before screening, or planned to donate blood or blood components during the study period or within 3 months after the end of the study; 17. Received any vaccinations within 14 days prior to screening; 18. The investigator believes that the subject has any other circumstances that are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum parathyroid hormone;serum total calcium;serum inorganic phosphorus;serum ionized calcium; | — |
Countries
China
Contacts
Public ContactHu Xingjiang
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed