Pain
Conditions
Interventions
Group 1:3.5mg (including 3 placebo cases):On the day of administration, a single intravenous dose of YZJ-4729 Tartrate Injection (3.5 mg) or placebo was given under fasting conditions, with an infusio
Group 2: 4.5mg (including 3 placebo cases):OOn the day of administration, a single intravenous dose of YZJ-4729 Tartrate Injection (4.5 mg) or placebo was given under fasting conditions, with an infus
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 18 to 45 years old (including the threshold) in the trial; 2) The weight of male trial participants shall not be less than 50kg, and the weight of female trial participants shall not be less than 45kg. Body Mass Index (BMI)=weight (kg)/height ^2 (m^2), with BMI ranging from 19.0 to 26.0kg/m^2 (including critical values); 3) Female trial participants with fertility have no fertility plan and have taken appropriate contraceptive measures (see Appendix 2: Contraceptive Measures, Definition of Women of Childbearing Age, and Contraceptive Requirements) from 2 weeks before screening to 90 days after the last administration, and male trial participants (with a partner who is a fertile female) have not signed the informed consent form and have taken appropriate contraceptive measures (see Appendix 2: Contraceptive Measures, Definition of Women of Childbearing Age, and Contraceptive Requirements) within 90 days after the last administration, and have avoided donating eggs/sperm; 4) Participants who can understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Allergic constitution, such as those known to have a history of allergies to two or more substances, or those known to be allergic to opioid drugs, or those with contraindications to the use of such drugs, or those known to have a history of allergies to YZJ-4729 tartrate injection and its excipients; 2) Individuals who have previously or currently suffered from respiratory system diseases (such as difficult airways, sleep apnea hypopnea syndrome), digestive system diseases (such as gastrointestinal obstruction), urinary system diseases, endocrine system diseases, nervous system diseases (such as epilepsy), hematological, immunological, psychiatric and other systemic diseases that have been determined by researchers to be unsuitable for inclusion; 3) Individuals with a history of cardiovascular disease, including but not limited to syncope or family history, coronary heart disease (such as coronary angiography diagnosis of coronary heart disease, acute coronary syndrome, myocardial infarction, etc.), valvular heart disease, heart failure, non drug-induced bradycardia, frequent ventricular premature beats, ventricular tachycardia, etc; Or prolonged QTc interval in the past or other risk factors (hypokalemia, etc.) of torsade de pointes ventricular tachycardia, or family history of short QT syndrome, long QT syndrome, sudden death, drowning or sudden infant death syndrome of unknown causes in youth (140mmHg, diastolic blood pressure90mmHg); Breathing20 times/minute; Pulse rate100 beats/minute), physical examination, 12 lead electrocardiogram, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), chest radiograph or CT, abdominal ultrasound results. The researcher determines that the abnormality has clinical significance and is not suitable for inclusion; 10) During screening, transcutaneous oxygen saturation is less than 95%; 11) Abnormal electrocardiogram results during screening have clinical significance, such as QTc>=450ms in males and>=460ms in females [QTc calculated using Fridericia's formula: QTcF=QT/(RR ^ 0.33)]; PR interval>=200ms; QRS duration>=120ms; 12) Individuals whose blood potassium, magnesium, and calcium levels exceed the upper limit of the normal reference range or are below the lower limit of the normal reference range during screening; 13) Individuals with any history of drug abuse or positive urine drug screening during the screening period; 14) Individuals who have undergone major surgeries or surgeries that may significantly affect the in vivo process or safety evaluation of the investigational drug within the 6 months prior to screening; 15) Individuals who frequently consume alcohol wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram indicators ;Vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Indicators; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital, Central South University
Outcome results
None listed