Pain
Conditions
Interventions
0.2 mg dose group:YZJ-4729 tartrate injection
0.5 mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
1 mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
2mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
3mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
4.5mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
6mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
7mg dose group:8 YZJ-4729 tartrate injection, 2 placebos
Part B:YZJ-4729 tartrate injection
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old <= age <=45 years old (calculated as the date of signing the informed consent), both sexes; 2. The weight of male subjects should not be less than 50kg, and the weight of female subjects should not be less than 45kg. Body mass index (BMI = weight (kg)/height 2(m2), BMI in the range of 19.0-26.0 kg/m2 (including the cut-off value); 3. In good health condition, no history of serious diseases or chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system; 4. Subjects (including partners) have no sperm donation plan, egg donation plan or pregnancy plan and have voluntarily taken effective contraception within 6 months from the signing of informed consent to the last administration of the test drug, and the specific contraceptive measures are listed in Appendix 2; 5. Voluntarily sign the informed inquiry letter before the test, and fully understand the test content, process and possible adverse reactions.
Exclusion criteria
Exclusion criteria: 1. A history of cardiovascular, respiratory (e.g., sleep apnea syndrome, pulmonary heart disease, or chronic bronchial wheeze), liver, kidney, nervous system (e.g., epilepsy), hematological, or psychiatric disorders considered clinically significant by the investigator; 2. History of cardiovascular system including but not limited to history of syncope or family history, coronary heart disease (such as coronary artery disease diagnosed by coronary angiography, history of acute coronary syndrome, history of myocardial infarction, etc.), valvular heart Disease, heart failure, history of non-drug-induced chronic arrhythmia, frequent premature ventricular contractions, ventricular tachycardia, etc.; Always extended between the QTc or have sophisticated other risk factors to reverse the type of ventricular tachycardia (hypokalemia, etc.), or a short QT syndrome, long QT syndrome, youth (less than or equal to 40 years old) sudden unexplained death, drowning or first-degree relatives of sudden infant death syndrome (that is, the biological parents, siblings, or children) family history. 3. A history of symptomatic head trauma; 4. History of frequent nausea or vomiting caused by any etiology; 5. History of glaucoma or any disease history that had an impact on the size of the Tong Tong; 6. Underwent major surgery or trauma within 6 months before screening or planned to undergo surgery during the study; 7. People with known allergies to two or more kinds of food or drugs; 8. People with known allergies to opioids or contraindications to the use of such drugs; 9. Difficulty in collecting blood through veins, or known history of needle sickness and blood sickness; 10. The female subjects were in lactation, PIH, prepregnancy or blood PIH with abnormal results and clinical significance at the time of screening; 11. Abnormal ECG results during screening have clinical significance, such as male QTcF>=450ms, female QTcF>=470ms:; PR interval >=200ms; QRS wave group duration >=120ms; 12. Abnormal vital signs at screening (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg: respiration 20 / min; pulse 100 / min; or physical examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), chest radiograph or CT, and abdominal color ultrasound abnormalities have clinical significance (subject to the judgment of clinicians); 13. Any abnormality of hepatitis B virus surface antigen, treponema pallidum specific antibody, human immunodeficiency virus antibody, or hepatitis C virus antibody during screening has clinical significance; 14. When screening, blood potassium, magnesium and calcium exceed the upper limit of normal reference range or are lower than the lower limit of normal reference range; 15. Blood oxygen saturation was less than 95% during screening; 16. Any drug abuse history within 1 year before screening or positive urine drug test during screening; 17. Regular drinkers (drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with 40% alcohol content or 150mL wine) or alcohol breath test results > 0mg/100mL, or consuming any alcoholic product within 48 hours before the first use of the test drug in the 6 months prior to screening, Or do not agree to avoid taking any alcoholic products during the trial; 18. Those who smoked more than 5 cigarettes per day within 3 months before screening, or had
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Pupil diameter;12-lead electrocardiogram;Vital signs;Oxygen saturation;Carbon dioxide expiration;Sleepiness score;Scores of nausea and vomiting;Addiction score;Physical examination; | — |
Countries
China
Contacts
Public ContactWen Ouyang/Guoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Outcome results
None listed