Stage 3, 4, and 5 chronic kidney disease secondary hyperparathyroidism
Conditions
Interventions
Pretest:The healthy subjects were enrolled orally with the test drug at a dose of 0.5 µg/person/day for single-dose administration tolerance, pharmacokinetics and pharmacodynamic pre-tests.
single ascending dose (SAD) study:The healthy subjects were enrolled in batches at doses of 0.5 µg, 1 µg, 2 µg, 4 µg, 8 µg/person/day, double-blind, randomly assigned oral test drugs or placebo for to
multiple ascending dose:The healthy subjects were enrolled in three doses of 0.5µg, 2µg, 4µg/person/day (the initial and subsequent doses could be adjusted according to the SAD results), and the patie
Effects of fasting and postprandial on CK15 absorption and pharmacokinetics in healthy subjects:Healthy subjects were enrolled in the open and random distribution of oral administration drugs of a sin
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects must meet all of the following criteria to be enrolled: 1) healthy volunteers aged between 18 and 45 years old (including boundary value), both male and female, whose health status was determined by the researchers according to the medical history, surgical history and all physiological examinations, including vital signs, electrocardiogram and laboratory examination results; 2) body weight: male body weight is greater than 50kg, female body weight is greater than 45kg, and the body mass index (BMI) of subjects is between 18 and 28kg/m2 (including boundary value); 3) subjects and their spouses agree to take effective contraceptive measures (effective contraceptive measures include tubal ligation, vasectomy, abstinence, condom use and intrauterine device) throughout the study period (from screening to 6 months after the end of the study); 4) subjects must give informed consent to the study before the test and sign a written informed consent voluntarily; 5) subjects can communicate well with researchers and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1. have any history of serious clinical disease or have a history of circulatory system, endocrine system, nervous system disease, blood system, immune system, or mental illness and metabolic abnormalities; 2. Those with a history of severe allergic diseases or allergies, or clear ingredients for this product or its preparations (medium chain oil, tert-butyl hydroxyanisole, 2,6-di-tert-butyl-p-cresol, glycerin and capsules) Gelatin) allergic; 3. Those who have suffered from gastrointestinal and liver and kidney diseases that affect drug absorption or metabolism; 4. Once suffering from chronic infectious diseases such as tuberculosis; 5. Patients who have had clinically significant disease or have undergone surgery within 4 weeks before the test; 6. Laboratory tests (blood routine, urine routine, blood biochemical examination, etc.) are found to have clinically significant abnormalities; (1) Patients with abnormal blood calcium (blood calcium 2.54 mmol/L); (2) Patients with abnormal blood free calcium (blood free calcium 1.6 mmol/L); (3) those with abnormal blood phosphorus (blood phosphorus 1.6 mmol/L); (4) abnormal blood iPTH (blood iPTH 65 pg/mL); 7. Electrocardiogram, chest X-ray with clinically significant abnormalities or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm); 8. Those with positive HIV test, positive for hepatitis B surface antigen (HBsAg), positive for treponema pallidum antibody (TP-Ab) or positive for hepatitis C test; 9. There is currently a large amount of alcohol (ie more than 14 units of alcohol per week [1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine]), or no smoking ban during the study period; 10. taking drugs (such as marijuana) 3 months before the test and during the test period or taking drugs (such as cocaine, phencyclidine, etc.) one year before the test and during the test; 11. Alcohol breath test, drug urinary screening test positive (cocaine, amphetamine, methamphetamine, morphine, methadone, marijuana, phencyclidine, barbiturates, benzodiazepines, tricyclic antibiotics) Depression) 12. Those who cannot comply with the unified diet; 13. Study a special diet (including grapefruit and/or scutellaria diet) within 7 days prior to enrollment, or study chocolate, any caffeinated food or beverage 48 hours prior to enrollment, or study 24 hours prior to enrollment Have taken any alcoholic products, or are unwilling to stop taking the above products during the study period; 14. Any drug that inhibits or induces liver metabolism of the drug 30 days before or during the test; 15. Smoking (using nicotine in the past 6 months) and positive nicotine testing during screening; 16. Those who have taken any prescription drugs within 14 days before the test; 17. participated in any drug clinical trial within 3 months prior to the trial; 18. Those who have given blood within 4 weeks prior to the trial or who plan to donate during the study period; 19. Female blood HCG positive 1 day before screening or administration; 20. It may be because other studies cannot be completed or the researcher believes that it should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;pharmacodynamics;vital signs;Physical examination;blood routine;Urine routine;Blood biochemistry;Coagulation;ECG;ECG;Adverse events; | — |
Countries
China
Contacts
Public ContactRui Wang,Yun Cai
Outcome results
None listed