Treatment of acute and chronic pain and pruritus
Conditions
Interventions
Dosage 1 group (Test drug):Single intravenous infusion of test drug of dosage 1 (vs placebo)
Dosage 1 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 1)
Dosage 2 group (Test drug):Single intravenous infusion of test drug of dosage 2 (vs placebo)
Dosage 2 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 2)
Dosage 3 group (Test drug):Single intravenous infusion of test drug of dosage 3 (vs placebo)
Dosage 3 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 3)
Dosage 4 group (Test drug):Single intravenous infusion of test drug of dosage 4 (vs placebo)
Dosage 4 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 4)
Dosage 5 group (Test drug):Single intravenous infusion of test drug of dosage 5 (vs placebo)
Dosage 5 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 5)
Dosage 6 group (Test drug):Single intravenous infusion of test drug of dosage 6 (vs placebo)
Dosage 6 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 6)
Dosage 7 group (Test drug):Single intravenous infusion of test drug of dosage 7 (vs placebo)
Dosage 7 group (placebo):placebo (vs single intravenous infusion of test drug of dosage 7)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects shall sign the informed consent before the test and have a full understanding of the test content, process and possible adverse reactions; Volunteer to participate and be able to complete the study according to the protocol; 2. Male or female subjects aged 18-50 years (including 18 and 50 years); 3. Weight >= 50 kg for males, >= 45 kg for females, BMI 19-26 kg/m2; 4. Subjects and their female partners are willing to have no childbearing plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening to 6 months after the last dose of the test drug, and to use one or more non-pharmaceutical contraceptives during sexual intercourse from 2 weeks prior to screening to 1 month after the last dose of the test drug.
Exclusion criteria
Exclusion criteria: 1. Those who have had or are suffering a disease with abnormal clinical presentation that needs to be excluded prior to screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive, haematological and lymphatic, urinary, endocrine, immune system disorders; 2. Those who have undergone major surgical procedures within 3 months prior to screening, or who are scheduled to undergo surgery during the trial, and those who have undergone any surgery that can affect the absorption, distribution, metabolism, or excretion of drugs; 3. Those who have took any drug that inhibits or induces hepatic metabolism of the drug (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, statins) within 28 days prior to screening; 4. Those who have used any prescription, over-the-counter, herbal, vitamin and health products within 14 days prior to screening; 5. Those who have a history of substance abuse, drug use or long-term drug use within the 6 months prior to screening; 6.Persons with a history of specific allergies (asthma, urticaria, eczema, etc.) or allergies (e.g. to two or more drugs, foods) or known hypersensitivity to components or analogues of the test drug. 7. Persons who have received a vaccination within 1 month prior to screening or who are scheduled to receive a vaccination during the trial 8. Those who have donated or lost >= 400 mL of blood within 3 months prior to screening, or those who plan to donate blood or blood components during or within 3 months after the trial; 9. Those who cannot tolerate venipuncture, or have a history of needle sickness or blood sickness; 10. Those who had smoked more than 5 cigarettes per day on average in the 3 months prior to screening, or who were unable to stop using any tobacco-based products during the trial; 11. Those who have drunk more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine) within 3 months prior to screening,or are unable to stopping drinking; 12. Those who have consumed excessive amounts of tea, coffee and/or caffeinated beverages (average of more than 8 cups, 1 cup is about 250 mL) on average per day during the 3 months prior to screening; 13. Those who have consumed or consumed dragon fruit, mango, grapefruit, poppy seeds or food or beverages prepared from them, or food or beverages containing xanthines, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that interfere with the absorption, distribution, metabolism or excretion of drugs within 48 h prior to admission; 14. Those who have special dietary requirements and cannot accept a uniform diet; 15. Female subjects who are pregnant or breastfeeding during the trial; 16. Those whose vital signs examination, physical examination, clinical laboratory tests, chest radiographs, 12-lead ECG findings show abnormalities with clinical significance; 17. A history of prolonged QTc interval, or QTcF > 450 ms, or an ECG result that is judged by the investigator to be clinically significant (Fridericia's correction formula: QTc = QT/RR0.33); 18. Those whose serum lactogen level exceeds the normal values; 19. Those who have Participated in another clinical trial within 3 months prior to screening and use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Urine drug concentration;Feces drug concentration;Visual Analogue Scale (VAS) score;Adverse effect;Blood routine examination;Blood biochemistry;Blood coagulation function examination;Urinalysis;12-lead electrocardiograph (ECG);injection site evaluation;Chest radiography;Urinary excretion assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pressure Pain Threshold;Visual Analogue Scale (VAS) score; | — |
Countries
China
Contacts
Public ContactWei hu
The Second Hospital of Anhui Medical University
Outcome results
None listed