chronic pain
Conditions
Interventions
A1:Single oral dosing of QR060127 capsules (dose level 1) or placebo
A2:Single oral dosing of QR060127 capsules (dose level 2) or placebo
A3:Single oral dosing of QR060127 capsules (dose level 3) or placebo
A4:Single oral dosing of QR060127 capsules (dose level 4) or placebo
A5:Single oral dosing of QR060127 capsules (dose level 5) or placebo
A6: Single oral dosing of QR060127 capsules (dose level 6) or placebo
A7:Single oral dosing of QR060127 capsules (dose level 7) or placebo
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subjects sign informed consents with full understanding of the test content, procedure, and possible adverse effects, and indicate the date of signing; 2. Healthy male or female Chinese volunteers aged 18-45 years; 3. Weight >= 50 kg for males,>= 45 kg for females, BMI 19-26 kg/m2; 4. Subjects agree to comply with the specified requirements for contraception and sperm and egg donation during the trial and for 3 months after drug administration; 5. Willingness to understand and comply with study procedures and limitations, ability to complete the trial as planned, and ability to communicate effectively with researchers.
Exclusion criteria
Exclusion criteria: 1. Previous history of allergic reactions to ingredients in the trial drug or other drugs and foods; 2. Participation in any other clinical trials within 3 months prior to screening and taking medications or receiving interventions, or planning to participate in other trials during the trial; 3. Subjects who have been vaccinated within 1 month prior to screening or have a vaccination schedule within 1 month of the start of the trial; 4. Non-physiological blood loss >= 200 ml (including trauma, blood collection, blood donation, etc.) within 60 days prior to dosing, or planned blood donation during the trial or within 30 days after dosing; 5. History of febrile illness or evidence of active infection within 14 days prior to dosing; 6. Previous history of skin disease or recent skin abnormalities that are judged by researchers to be clinically significant or may affect the evaluation of the test; 7. Previous history of ocular disease or recent ocular abnormalities that are judged by researchers to be clinically significant or may affect the evaluation of the trial; 8. The presence of clinically significant systemic diseases or medical history, including but not limited to circulatory, gastrointestinal, endocrine, neurological, respiratory, immune, genitourinary, or psychiatric disorders, or other clinically significant diseases, conditions, or other evidence that, in the opinion of researchers, would pose a risk to the safety of the subject or interfere with the conduct or completion of the study; 9. Major surgical procedure within 6 months prior to screening or planned to be performed during the study period; 10. History of previous prolonged QTc interval or QTcF >= 450 ms (men) or 470 ms (women), or abnormal clinically significant ECG findings as judged by researchers; 11. Clinical tests such as physical examination, vital sign measurements, and any laboratory test results that are judged by researchers to be abnormal and clinically significant; 12. Female subjects who are pregnant or breastfeeding or who are planning to become pregnant within 1 month prior to the start of the trial and during or within 3 months after the trial; 13. Female subjects with positive serum pregnancy tests at screening or baseline; 14. Positive screening results for infectious diseases, including hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, HIV antibody and syphilis spirochete antibody tests; 15. History of drug abuse within 5 years prior to screening, or positive urine drug abuse screening results at baseline; 16. Excessive use of nicotine products (more than 5 cigarettes per day on average) in the 3 months prior to screening or inability to stop using any tobacco product during the trial; 17. Regular drinkers within 3 months prior to screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45mL of spirits at 40% alcohol or 150 mL of wine) or positive alcohol screen; 18. Ingestion of xanthine/caffeine-containing foods or beverages within 48 h prior to drug administration; 19. Those who have used any prescription and over-the-counter medications, any vitamin products or herbal remedies within 14 days prior to screening; 20. Any drug or other possible substance that regulates the metabolism of CYP3A4 and CYP2C19 (e.g. herbs, grapefruit, etc.) planned to be used within 14 days prior to screening or during the trial; 21. Those who have special dietary requirements and cannot follow a unif
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Urine drug concentration;Fecal drug concentration;Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram; Routine 12-leads electrocardiogram;Urine Ras1 concentration; | — |
Countries
China
Contacts
Public ContactHui Zhao and Wei Hu
Drug Clinical Trial Research Center, The Second Hospital of Anhui Medical University
Outcome results
None listed