Pain
Conditions
Interventions
Part1 25mg:Single oral administration of 25mg HRS6257 tablets or placebo under fasting conditions. 8 cases received HRS-6257, and 2 cases received a placebo.
Part1 50mg:Single oral administration of 50mg HRS6257 tablets or placebo under fasting conditions. 8 cases received HRS-6257, and 2 cases received a placebo.
Part1 100mg:Subjects will receive a total of 2 administrations. In the first period, they will be given 100mg HRS6257 tablets or placebo under fasting conditions
in the second period, they will be given 100mg HRS6257 tablets or placebo after meals. The washout period between the two periods is 7 days. 8 cases received HRS-6257, and 2 cases received a placebo.
Part1 200mg:Single oral administration of 200mg HRS6257 tablets or placebo under fasting conditions.8 cases received HRS-6257, and 2 cases received a placebo.
Part1 400mg:Single oral administration of 400mg HRS6257 tablets or placebo under fasting conditions.8 cases received HRS-6257, and 2 cases received a placebo.
Part2 25mg:Subjects will receive 25mg HRS6257 tablets or placebo once each in the morning and evening under fasting conditions from Day 1 to Day 14 (only one dose will be administered in the morning o
Part2 50mg:Subjects will receive 50mg HRS6257 tablets or placebo once each in the morning and evening under fasting conditions from Day 1 to Day 14 (only one dose will be administered in the morning o
Part2 100mg:Subjects will receive 100mg HRS6257 tablets or placebo once each in the morning and evening und
Sponsors
Xiangya Third Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, the age range is between 18 and 55 years old (including the threshold), and both males and females are eligible; 2. During the screening period, male weight >= 50 kg, female weight >= 45 kg, and body mass index (BMI=weight (kg)/height ^2 (m^2)) between 19-28 kg/m^2 (including boundary values); 3. The subjects and their partners have no plans to conceive, donate sperm, or eggs within 2 months after signing the informed consent form until the last time they received the investigational drug, and voluntarily adopt efficient contraceptive measures (see Section 13.1.2); Female subjects with fertility must undergo serum pregnancy tests during the screening and baseline periods, and the results must be negative; 4. Female subjects: non pregnant or lactating; 5. The skin of the area receiving pain stimulation has no wounds or skin diseases; 6. Willing to undergo pain testing and pass training; 7.The subjects have a detailed understanding of the nature, significance, potential benefits, potential inconveniences, risks, and discomfort of the trial before the trial, are able to understand the procedures and methods of this study, are willing to strictly comply with the requirements of the entire clinical study, and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have previously or currently suffered from clinical acute or chronic diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, and have been determined by researchers to be unsuitable for inclusion; 2. Screening period or baseline period: For patients with aspartate aminotransferase, alanine aminotransferase, total bilirubin, and serum creatinine exceeding the upper limit of the normal range, QTcF>450 ms, or those with clinically significant hyperkalemia or hypokalemia determined by researchers to be abnormal; 3. Individuals with a history of apical torsion type ventricular tachycardia, symptomatic ventricular arrhythmia, or a personal or family history of short QT syndrome or long QT syndrome; 4. Subjects with hemoglobin abnormalities such as hemolytic disease, G6PD deficiency, and thalassemia, as well as anemic diseases in the past; 5. Individuals with a known history of allergies to the investigational drug or its excipients, a history of chronic urticaria, severe allergic reactions, or an allergic constitution (allergic to two or more drugs and food); 6. Individuals with a history of hereditary angioedema and family history; 7. Select patients who have undergone major surgeries within the previous 6 months, or who have undergone surgeries that may significantly affect the pharmacokinetic characteristics or safety evaluation of the study drug (such as gastrectomy, liver and kidney transplantation), or who plan to undergo surgery during the trial period; 8. Those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotic drugs, verapamil, fluoroquinolones, antihistamines) within one month before administration; 9. Select individuals who have received the vaccine within the previous month or plan to receive the vaccine during the trial period; 10. Those who have used any medication or health supplement (including Chinese herbal medicine) within the first 7 half lives or 14 days (whichever is longer) before administration, or those who may need to receive other medication treatment during the screening period known to be the trial period; 11. Select individuals who have participated in clinical trials and received the investigational drug within the previous 3 months, or who plan to participate in other clinical trials during the trial period; 12. Select individuals who have donated blood/lost blood >= 200 mL within the first 6 months (excluding physiological bleeding in females), received blood transfusions or used blood products, or plan to donate blood during the trial period or within 1 month after the trial ends; 13. Select individuals who have smoked an average of more than 5 cigarettes per day within the past 3 months, or who are unable to quit smoking during the trial period; 14. Select individuals who have consumed an average of more than 14 units of alcohol per week within the previous 3 months (1 unit ˜ 285 mL of beer with an alcohol content of 3.5%, or 25 mL of strong liquor with an alcohol content of 40%, or 85 mL of wine with an alcohol content of 12%), or who do not agree to abstain from alcohol during the trial period; 15. Screening for individuals who have consumed excessive amounts of tea, cof
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 lead electrocardiogram indicators;Vital signs;Holter monitor indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Pain threshold ; | — |
Countries
China
Contacts
Public ContactYang Guoping
Xiangya Third Hospital, Central South University
Outcome results
None listed