GoutHyperuricemia
Conditions
Interventions
The low-dose group of Teninade:QD, 40mg, 80mg, 120mg
Duration:7day
The Teninade placebo group:QD, 40mg, 80mg, 120mg
Duration:7day
Sponsors
Beijing hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjects aged 18-45 years (inclusive) at screening, based on the date of signing the informed consent form (ICF). 2.Body mass index (BMI = weight[kg]/height[m]^2) between 18.0 and 28.0 kg/m^2 (inclusive), with male subjects weighing >=50 kg and female subjects weighing >=45 kg. 3.No clinically significant abnormalities in vital signs, physical examination, laboratory tests (except serum uric acid), 12-lead ECG, chest X-ray, or urinary system ultrasound during screening. 4.Subjects of childbearing potential must agree to use medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms; see Appendix 1 for details) during the trial and for 3 months after trial completion, with no plans to donate sperm/eggs during this period. 5.Serum uric acid (sUA) level >=4 mg/dL (240 µmol/L) and <=7 mg/dL (420 µmol/L) at screening. 6.Subjects must fully understand the trial's purpose, procedures, potential risks, and voluntarily sign the ICF, demonstrating compliance with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Participation in any interventional clinical trial within 3 months prior to screening. 2. Vaccination within 1 month before the first dose or planned vaccination during the trial period. 3. Female subjects who are pregnant or breastfeeding. 4. Known history of severe allergies, non-allergic drug reactions, food or drug allergies, or known hypersensitivity to the investigational drug (active pharmaceutical ingredient or excipients). 5. Presence of any significant disease symptoms or relevant medical history, including but not limited to cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine, metabolic, lymphatic, hematological, immunological, ophthalmic, dermatological, psychiatric, and genitourinary system disorders, or any other disease or physiological condition that may interfere with trial results. 6. Any surgical condition or disease that may significantly affect drug absorption, distribution, metabolism, or excretion, or any medical treatment, surgical condition, or disease that may pose risks to subjects: e.g., planned major surgery during the trial, history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, bowel resection, etc.), urinary obstruction or dysuria, history of peptic ulcers or gastrointestinal bleeding. Note: Subjects who have undergone appendectomy or hernia repair could be enrolled. 7. History of hyperuricemia and/or gout, or use of drugs affecting uric acid synthesis, metabolism, or excretion within 1 month prior to screening; history of or suspected urolithiasis during screening based on ultrasound findings. 8. Estimated glomerular filtration rate (eGFR) =400 mL within 3 months prior to screening; or >=200 mL within 1 month prior to screening; or planned blood donation during the study. 13. Consumption of food or beverages that may affect liver metabolism (e.g., starfruit, pomelo, grapefruit) within 14 days before the first dose. 14. Regular use of nicotine products or smoking (>5 cigarettes/day) within 3 months prior to screening, and/or unwillingness to abstain from smoking or nicotine products during the study. 15. Alcohol intake >14 units/week (1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine) within 6 months prior to screening; or positive alcohol breath test at baseline; or unwillingness to abstain from alcohol during the study. 16. Unwillingness to abstain from caffeinated beverages (e.g., tea, coffee) from 24 hours before the first dose until the end of the study. 17. Positive for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab). 18. History of unexplained syncope, cardiac arrest, unexplained arrhythmia, torsades de pointes, structural heart disease, or family history of long QT syndrome. 19. Investigator's judgment of unsuitability for participation due to scientific, compliance, or safety reasons. 20. Close relationship with the research site (e.g., immediate family member of the investigator or site s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs);Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs);The following indicators showed clinically significant changes from the baseline: laboratory evaluations (blood routine, blood biochemistry, urine routine, coagulation tests); - 12-lead electrocardiogram (ECGs); - vital signs; - physical examination. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum uric acid (sUA): Maximum value and area under the concentration curve (AUCsUA);Urinary uric acid concentration (UUA) ;24-hour urinary uric acid excretion volume (AeUR);24-hour urinary uric acid clearance rate (CLUR);24-hour urinary uric acid excretion fraction (FEUA);Steady-state minimum plasma drug concentration (Css,min);Steady-state maximum plasma drug concentration (Css,max) ;Steady-state average plasma drug concentration (Css,avg);Peak time of steady-state blood drug concentration (tmax);Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) within the dosing interval;Terminal phase elimination rate constant (?z);Terminal phase elimination half-life (t1/2);Apparent clearance rate (CLss/F);Terminal phase apparent volume of distribution (Vss/F); The accumulation ratio (Rac(AUC)) calculated based on AUC and the accumulation ratio (Rac(Cmax)) calculated based on Cmax;The cumulative excretion in urine of the drug from the time of administration until the last measurable concentration is measured (Aelast) ;The percentage of the drug dosage that is excreted into the urine from the time of administration until the last measurable concentration is collected (Aelast%);The cumulative amount of the study drug excreted into urine from the time of administration to infinity (Aeinf);The percentage of the study drug excreted into urine from the time of administration to infinity (Aeinf%);Renal clearance rate (CLR);The excretion fraction of the drug in urine from 0 to 24 hours (Fe0-24h);Analysis of the metabolite spectrum of teninade in plasma and urine; | — |
Countries
China
Contacts
Public ContactShi Aixin
Beijing hospital
Outcome results
None listed