Pain
Conditions
Interventions
Single, Food affected, Multiple:Oral
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult male/female aged in 18 - 55 years; 2. Body Weight is in the range of >= 45 kg for female and >= 50 kg for male; BMI is in the range of 19 - 28 kg/m2; 3. Subjects who have not had unprotected sex within 2 weeks prior to screening, and are willing to have no birth plan and will voluntarily take effective contraceptive measures from the beginning of screening to 6 months after the last drug administration; 4. The subjects fully understand the trial content, process and potential adverse reactions, and are willing to complete the study according to the requirements of the protocol, and voluntarily sign a written ICF.
Exclusion criteria
Exclusion criteria: 1. The results of physical examination, clinical laboratory examination, virology examination, vital signs or any other examination results are abnormal and clinically significant as judged by the investigator; 2. Subjects participating in the food impact trial could not tolerate high-fat meals, or the subjects could not accept the uniform diet provided during the study; 3. Those who plan to participate in vigorous exercise or strenuous physical labor from the screening period to the end of the follow-up; 4. Previous alcohol abuse or regular drinking in the 6 months prior to the trial; 5. Those previously or currently suffering from serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood and lymphatic system, urogenital system, or virology and psychiatry, who are not suitable for enrollment judged by the investigator; 6.Those who have taken any medication including but not limited to prescription, over-the-counter or Chinese herbal medicine within 14 days prior to initial administration; 7. Those who received vaccine injection within 1 month before the first administration; 8. Those who are known to be hypersensitivity to the active ingredient of JMKX000623 and its excipients, or any component of nerve blocking medication; 9. Those who participate in any other clinical trials within 3 months prior to initial dosing in this study; 10.Those with QTc>450 ms of ECG at screening, or other conditions in ECG results that are clinically significant as judged by the investigator; 11. Those who had consumed grapefruit-, or grapefruit-containing, caffeine, alcohol or other ingredients diet within 48 hours before the first administration of the drug, or those who did not agree to be prohibited from ingesting the above-mentioned diet during the trial period; 12. Those who had smoked more than 5 cigarettes per day on average within 3 months prior to screening, or who do not agree with the smoking ban or have a positive nicotine/cotinine test during screening; 13. Those with donation of blood or blood products within 3 months prior to first dosing till 1 month after the end of the last dosing; 14. Those who have drug abuse history; 15. Those with positive results of urine drug screening or alcohol screening; 16. Subjects with any other factors that the investigator considers who are inappropriate to participate in this trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of JMKX000623 tablets after administration; | — |
Countries
China
Contacts
Public ContactXiuli Zhao
Outcome results
None listed