Chronic non-cancer pain
Conditions
Interventions
1:One dose of YR-1702 injection at a dose and mode of administration of 0.1 mg intravenously for 2 min for a 7-day safety study.
2:Subjects are randomly assigned in a 1:1 ratio to one of 2 dosing sequence groups (TC group, CT group). Subjects receive one intravenous infusion of YR-1702 injection (0.1 mg) or morphine hydrochlori
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. 18 years <= age <= 55 years of age (calculated on the date of signing the informed consent form), half of each sex; 2. Chronic non-cancer pain patients (e.g., patients with frozen shoulder, chronic low back pain, myofascial pain syndrome, etc.); 3. Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg; body mass index (BMI) = weight (kg)/height2 (m2), BMI within BMI was within the range of 9.0~26.0 kg/m2 (including the threshold value); 4. Subjects (including partners) had no plans for sperm donation or egg donation, no plans for pregnancy and voluntarily took effective contraceptive measures within 6 months from the signing of the informed consent to the last dose of the test drug (see Appendix 2 for specific contraceptive measures); 5. Subjects voluntarily signed the informed consent form before the test and fully understood the content, procedure, and possible adverse effects of the test. The trial participants were fully informed of the trial content, procedure, and possible adverse effects.
Exclusion criteria
Exclusion criteria: 1. History of respiratory (e.g., sleep apnea syndrome, pulmonary heart disease, or bronchial asthma), hepatic, renal, neurological (e.g., epilepsy), hematologic, or psychiatric abnormalities of clinical significance in the opinion of the investigator; 2. History of cardiovascular disease including, but not limited to, a history or family history of syncope, coronary artery disease (e.g., coronary angiography for diagnosis of coronary artery disease, history of acute coronary syndrome, history of infarction, etc.), valvular history of coronary artery disease (e.g., coronary angiography, acute coronary syndrome, infarction, etc.), valvular heart disease, heart failure, history of non-drug induced bradyarrhythmias, frequent premature ventricular contractions, ventricular tachycardia, etc.; or history of prolonged QTc interval or other risk factors for previous tip-twist ventricular tachycardia (hypokalemia, etc.), or first-degree sudden death, drowning, or sudden infant death syndrome of unknown origin in youth (less than/equal to 40 years of age) with short QT syndrome, long QT syndrome, or family history of a relative (i.e., biological parent, sibling, or child); 3. Rheumatic immune system disorders such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, etc.; 4. History of symptomatic head trauma; 5. History of frequent nausea or vomiting of any etiology; 6. History of glaucoma or any disease affecting pupil size; 7. Major surgery or trauma within 6 months prior to screening; 8. Known allergy to two or more foods or medications; 9. Known allergy to opioids or contraindication to the use of such medications; 10. Difficulty with venous blood collection or known history of needle or blood sickness; 11. Female subjects who are lactating, pregnant, or preparing for pregnancy at the time of screening or whose blood pregnancy test results are clinically significant; 12. Abnormal ECG results at the time of screening that are clinically significant, such as QTcF >= 450 ms in men and QTcF >= 470 ms in women; PR interval >= 200 ms; QRS wave group time limit >= 120 ms; 13. Abnormal vital signs at the time of screening ( systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse 100 beats/min) or physical examination, laboratory tests (routine blood, urine, blood biochemistry, coagulation function) abnormalities have clinical significance (subject to the judgment of the investigator); 14. Screening of blood potassium, blood magnesium, and blood calcium outside the normal reference range; 15. Any clinically significant abnormality in hepatitis B virus surface antigen, syphilis spirochete-specific antibody, human immunodeficiency virus antibody, or hepatitis C virus antibody at screening; 16. Blood oxygen saturation less than 95% at screening; 17. History of any drug abuse or positive urine drug test within 1 year prior to screening; 18. Regular alcohol drinker within 6 months prior to screening (more than 14 units per week) alcohol [1 unit = 360mL of beer or 45mL of 40% alcohol spirits or 150mL of wine]) or alcohol breath test results >0mg/100mL within 6 months prior to screening, or have taken any alcohol-containing product within 48 hours prior to the first use of the test drug, or do not agree to avoid any alcohol-containing product during the test; 19. Have donated blood or lost a significant amount of blood (>400 mL, excluding blood loss during menstruatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Pupil diameter;Safety evaluation index; | — |
Countries
China
Contacts
Public ContactGuoping Yang, Wen Ouyang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed