Treat acute and chronic pain.
Conditions
Interventions
Dose Group 2:10 subjects received HBW-004285 tablet at 300 mg once daily for 14 consecutive days, and 2 received placebo.
Dose Group 3:10 subjects received HBW-004285 tablet at 800 mg once daily for 7 consecutive days, and 2 received placebo.
Dose Group 1:8 subjects received a single dose of HBW-004285 tablet at 1200 mg, and 2 received placebo.
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent must be obtained prior to any trial-related activities, and subjects must fully understand the purpose and significance of the trial and be willing to comply with the protocol; 2. Age between 18 and 55 years (inclusive); 3. Male subjects must weigh >=50.0 kg, female subjects must weigh >=45.0 kg; body mass index (BMI) = weight (kg) / height^2 (m^2), with BMI ranging from 19.0 to 26.0 kg/m^2 (inclusive); 4. Subjects must have had no unprotected sexual intercourse in the two weeks prior to screening, and must be willing to avoid pregnancy from the time of screening until three months after the last dose of study drug, using effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Presence of any clinically significant disease in the cardiovascular, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with trial outcomes; 2. History of allergy to drugs, food, or other substances; 3. Inability to tolerate venipuncture or difficulty with venous blood collection, or history of fainting or syncope related to needles or blood; 4. History of major surgery within 3 months prior to the trial, or planned surgery during the study period; 5. Use of any medication or health supplement (including traditional Chinese medicine) within 14 days prior to the trial; 6. Use of any drug that inhibits or induces hepatic drug metabolism within 30 days prior to the trial (e.g., inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Participation in any clinical trial and use of any investigational drug within the past 3 months; 8. Donation of blood or significant blood loss (>=200 mL, excluding menstrual blood loss), receipt of blood transfusion, or use of blood products within the past 3 months; 9. Pregnancy or lactation, or inability to use one or more effective non-pharmacological contraceptive methods during the trial period; 10. Special dietary requirements that prevent adherence to the standardized diet, or presence of dysphagia; 11. Daily consumption of excessive tea, coffee, and/or caffeine-containing beverages (>8 cups, 1 cup = 250 mL); 12. Positive nicotine test prior to first study drug administration, or smoking more than 5 cigarettes per day in the past 3 months, or inability to cease use of any tobacco products during the trial; 13. Positive alcohol test prior to first study drug administration, or frequent alcohol consumption within the past 6 months (i.e., >14 alcohol units per week; 1 unit = 360 mL beer, or 45 mL of 40% alcohol spirits, or 150 mL wine), or inability to cease use of any alcoholic products during the trial; 14. Positive drug test prior to first study drug administration, or use of soft drugs (e.g., cannabis) within the past 3 months, or use of hard drugs (e.g., cocaine, phencyclidine) within the past year; 15. Abnormal vital signs (systolic blood pressure =140 mmHg; diastolic blood pressure =90 mmHg; heart rate 100 bpm), or clinically significant abnormalities in physical examination, ECG, chest X-ray (posteroanterior), abdominal ultrasound, echocardiography, or laboratory tests (as determined by the clinical investigator); 16. Positive serological screening for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis treponema antibody; 17. Presence of cardiac disease, including but not limited to congenital long QT syndrome, torsades de pointes, or risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome); current use of Class IA [e.g., quinidine or procainamide] or Class III [e.g., amiodarone or sotalol] antiarrhythmic drugs, or other drugs known to affect QT interval; or corrected QT interval (QTcF) by Fridericia’s formula >=450 ms (males), >=470 ms (females), or PR interval >200 ms, or QRS duration >=120 ms at screening; 18. Receipt of any live vacci
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram;Vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital Central South University
Outcome results
None listed