Stage 3, 4, and 5 chronic kidney disease secondary hyperparathyroidism
Conditions
Interventions
single ascending dose (SAD) -4 µg:This group of subjects underwent double-blinding and were randomly assigned to receive either 4 µg of the oral test drug or a placebo. Six subjects received the oral
single ascending dose (SAD) -8 µg:This group of subjects underwent double-blinding and were randomly assigned to receive either 8 µg of the oral test drug or a placebo. Six subjects received the oral
single ascending dose (SAD) -12 µg:This group of subjects underwent double-blinding and were randomly assigned to receive either 12 µg of the oral test drug or a placebo. Six subjects received the ora
single ascending dose (SAD) -16 µg:This group of subjects underwent double-blinding and were randomly assigned to receive either 16 µg of the oral test drug or a placebo. Six subjects received the or
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 18 to 45 years (inclusive), both males and females, with health status determined by the investigator based on medical and surgical history, and all physical examinations, including: vital signs, electrocardiogram, and laboratory test results; 2. Weight: males weighing more than 50 kg, females weighing more than 45 kg, with a body mass index (BMI) between 18 and 28 kg/m^2 (inclusive); 3. The subject and their spouse agree to use effective contraceptive measures throughout the study period (from screening to 6 months after the end of the trial) (effective contraceptive methods include: tubal ligation, vasectomy, abstinence, use of condoms, intrauterine devices); 4. The subject must provide informed consent for the study prior to trial initiation and voluntarily sign a written informed consent form; 5. The subject is able to communicate effectively with the investigator and is capable of completing the study in accordance with the stipulated protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of any severe clinical disease or conditions affecting the circulatory, endocrine, nervous, hematopoietic, immune systems, or with psychiatric disorders and metabolic abnormalities; 2. Individuals with a history of severe allergic diseases or allergic constitution, or those who have a known allergy to this product or its excipient components (medium-chain triglycerides, butylated hydroxyanisole, butylated hydroxytoluene, glycerin, and gelatin for capsules); 3. Individuals with a history of gastrointestinal, hepatic, or renal diseases that could affect drug absorption or metabolism; 4. Individuals with a history of chronic infectious diseases, such as tuberculosis; 5. Individuals who have had a clinically significant illness or undergone surgical procedures within 4 weeks prior to the study; 6. Individuals with clinically significant abnormalities detected in laboratory tests (complete blood count, urinalysis, blood chemistry, etc.) a. Abnormal serum calcium levels (2.54 mmol/L); b. Abnormal serum phosphorus levels (1.6 mmol/L); c. Abnormal serum intact parathyroid hormone (iPTH) levels (65 pg/mL); 7. Individuals with clinically significant abnormalities in electrocardiogram (ECG), chest X-ray, or vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm); 8. Individuals testing positive for HIV, hepatitis B surface antigen (HBsAg), Treponema pallidum antibodies (TP-Ab), or hepatitis C; 9. Individuals who currently consume large amounts of alcohol (i.e., more than 14 units of alcohol per week [1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine]), or those who cannot abstain from smoking or alcohol during the study period; 10. Individuals who have used drugs (e.g., marijuana) within 3 months prior to the study or during the study period, or have used drugs (e.g., cocaine, phencyclidine, etc.) within one year prior to the study or during the study period; 11. Individuals with positive results in alcohol breath tests or drug urine screening tests (morphine, methamphetamine, ketamine, MDMA, delta-9-tetrahydrocannabinol); 12. Individuals who cannot comply with a standardized diet; 13. Individuals who have consumed a special diet (including grapefruit and/or xanthine-rich diets, etc.) within 7 days prior to study enrollment, or who have ingested chocolate, any caffeine-containing food or beverage within 48 hours before study enrollment, or consumed any alcoholic products within 24 hours before study enrollment, or are unwilling to discontinue the intake of the above products during the study period; 14. Smokers (who have used nicotine within the past 6 months) and those with a positive nicotine test at screening; 15. Individuals who have taken any prescription medications within 14 days prior to the study; 16. Individuals who have participated in any drug clinical trials within the last 3 months; 17. Individuals who have donated blood within 4 weeks prior to the study or plan to donate blood during the study period; 18. Females with a positive serum human chorionic gonadotropin (hCG) test on the day of screening or the day before dosing; 19. Individuals who may be unable to complete the study due to other reasons, or whom the investigator deems should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;pharmacodynamics;vital signs;Physical examination;Blood Routine;Urine routine;Blood biochemistry;Coagulation;ECG;Adverse events; | — |
Countries
China
Contacts
Public ContactYun Cai
Chinese PLA General Hospital
Outcome results
None listed