Ease the pain
Conditions
Interventions
Group 25mg:Oral administration of 25mg HRS2129
Group 75mg:Oral administration of 75mg HRS2129
Group 150mg:Oral administration of 150mg HRS2129
Group 300mg:Oral administration of 300mg HRS2129
Group 300mg:Oral administration of 600mg HRS2129
Placebo group:Placebo
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. The age at which the informed consent is signed is between 18 and 55 years old (including the boundary value) , both male and female. 2. In the screening period, male weight >=50 kg, female weight >=45 kg, body mass index (BMI = weight (kg)/height ^2(m ^2)) between 19-28 kg/m ^2(including boundary value) ; 3. The subjects and their partners had no plan of birth, sperm donation and egg donation from the signing of informed consent to 6 months after the last acceptance of the experimental drug, and voluntarily used effective contraception (see section 13.1.2) Fertile female subjects had to undergo a serum pregnancy test at screening and baseline, and the results were negative. 4. Female subjects: not pregnant or lactating; 5. There are no cuts or skin lesions on the skin that received the painful stimulation. 6. Willing to take the cold pain test and be trained; 7. The subjects had a detailed understanding of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomfort before the trial, and were able to understand the procedures and methods of this study, willing to strictly comply with the requirements of the whole clinical study, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have or are currently suffering from clinical acute and chronic diseases such as circulatory, endocrine system, nervous, digestive, respiratory, hematological, immunological, psychiatric and metabolic disorders, those judged unsuitable by the researchers; 2. Screening period or baseline: aspartate aminotransferase, alanine aminotransferase, total bilirubin, serum creatinine above the upper limit of the normal range, QTcF > 450 ms, or hyperkalemia and hypokalemia which were abnormal and clinically significant judged by the researcher; 3. Previous history of torsades de tachycardia, symptomatic ventricular arrhythmias, or personal or family history of short QT syndrome or Long QT syndrome. 4. Known allergies to research drugs or excipients of research drugs, or allergic constitution (allergy to 2 or more drugs and food) ; 5. Patients who had undergone major surgery within 6 months prior to screening, or who had previously undergone surgery (EG, gastrectomy, liver or kidney transplantation) that may significantly affect the pharmacokinetic profile or safety evaluation of the study, or plan to have surgery during the trial; 6. Use of any drug (e.g. inducer-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole, inhibitor-SSRI antidepressants, cimetidine, Diltiazem, Macrolide, nitro-imidazole, sedative-hypnotic, verapamil, fluoroquinolones, antihistamines) that inhibits or induces hepatic drug metabolism within 1 month before administration; 7. Those who have been vaccinated within 1 month before screening or who plan to be vaccinated during the trial; 8. Use of any drug or health product (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or in a trial where the screening period is known to require additional drug treatment; 9. Those who had been in a clinical trial and received the drug within 3 months before screening, or those who planned to participate in other clinical trials during the trial; 10. Blood donation/blood loss >=400 mL within 3 months before screening (except for female physiological blood loss) , receiving blood transfusion or using blood products, or planning to donate blood during the trial or within 1 month after the end of the trial; 11. Those who smoked more than 5 cigarettes per day in the 3 months before screening, or could not quit smoking during the trial; 12.Drinking an average of more than 14 units of alcohol per week during the 3 months before screening (1 unit ˜285 mL of beer with an alcohol content of 3.5% , or 25 mL of spirits with an alcohol content of 40% , or 85 mL of wine with an alcohol content of 12%) ; Or disapproved of abstinence during the trial; 13. Drinking excessive amounts of tea, coffee or caffeinated beverages (an average of 8 or more cups per day, or 1 cup = 200 mL) every day for 3 months before screening. 14. Consumption of special foods (e.g. grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine, etc.) within 48 hours before administration. 15. Those who have special dietary requirements and can not follow the same diet; 16. Screening or baseline physical examination results judged by the study physicians to be clinically significant; 17. People who test positive for one or more of the hepatitis B surface antigen, Hepatitis C virus antibody, syphilis or human immunodeficiency virus antibodies. 18. Drug abuse history or drug abuse screening pos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| vital signs;electrocardiogram (ECG);Concentration of HRS2129 in plasma;PK parameters; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed