Postoperative pain
Conditions
Interventions
10 mg(TRD208):Single intravenous administration, with 10 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.
30 mg(TRD208):Single intravenous administration, with 30 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.
60 mg(TRD208):Single intravenous administration, with 60 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.
120 mg(TRD208):Single intravenous administration, with 120 mg of TRD208 or placebo infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100
200 mg(TRD208):Single intravenous administration, with 200 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.
300 mg(TRD208):Single intravenous administration, with 300 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.
10 mg(placebo):Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml
30 mg(placebo):Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml
60 mg(placebo):Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Before the trial, the subjects had thoroughly understood the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial. They were able to understand the procedures and methods of this study, were willing to strictly abide by the requirements of the entire clinical research, and voluntarily signed the informed consent form. 2. Healthy subjects aged 18 to 55 years old (including the boundary value, based on the time of signing the informed consent form), regardless of gender; 3. The body mass index (BMI) is within the range of 19 to 28 kg/m ² (including the critical value), with a weight of 50 kg for men and 45 kg for women. 4. The subject and his/her partner had no plans to have children, donate sperm or eggs within 6 months from the signing of the informed consent form to the last acceptance of the trial drug, and voluntarily adopted efficient contraceptive measures (see Appendix 2); Female subjects with fertility must undergo serum pregnancy tests during the screening period and baseline period, and the results must be negative. 5. The skin at the site of pain stimulation has no wounds or skin diseases. 6. Those who are willing to undergo pain tests and pass the training.
Exclusion criteria
Exclusion criteria: 1.Those who have previously or currently suffer from acute or chronic clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic disorders, and are determined by the researcher to be unsuitable for enrollment; 2.Those who are known to be allergic to NSAIDs or have an allergic constitution (with a history of allergy to two or more drugs or foods); 3.Those with a history of or combined aspirin asthma; 4.Have any pre-existing or concurrent diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers, etc. 5.Screening period or baseline period: Individuals with aspartate aminotransferase, alanine aminotransferase, total bilirubin, or serum creatinine levels exceeding the upper limit of the normal range, or those with hyperkalemia or hypokalemia that have been identified as abnormal by the researcher and have clinical significance; 6.Those with a history of tortuous pointed-point ventricular tachycardia, symptomatic ventricular arrhythmia, or a personal or family history of short QT syndrome or long QT syndrome; 7.Those with a history or concurrent conditions of the following diseases: cardiovascular diseases [such as heart failure (such as fluid retention and edema), unstable ischemic heart disease, congestive heart failure, poorly controlled coronary artery disease, myocardial infarction, etc.] 8.Those who have had severe infections, trauma or undergone heavy major surgeries within 6 months prior to signing the ICF, or who have previously undergone surgeries that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug (such as liver or kidney transplantation), or who plan to undergo surgery during the trial period; 9.Within one month prior to administration, any drugs that inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors -Patients with SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and antihistamines; 10.Those who have been vaccinated within one month prior to signing the ICF or plan to be vaccinated during the trial period; 11.Those who have used any drugs or health supplements (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or those who have known during the screening period that they may need to receive other drugs during the trial period"Physical therapist;" 12.Those who have participated in clinical trials and received the trial drugs within three months prior to signing the ICF, or those who plan to participate in other clinical trials during the trial period; 13. Those who have donated or lost at least 400 mL of blood within 3 months prior to signing the ICF (excluding physiological blood loss in women), received a blood transfusion or used blood products, or plan to donate blood during the trial or within 1 month after the trial ends; 14.Those who smoked an average of more than five cigarettes per day in the three months prior to signing the ICF, or were unable to quit smoking during the trial period; 15.Those who consumed an average of more than 14 units of alcohol per week in the three months prior to signing the ICF (1 unit ˜285 mL of beer with an alcohol content of 3.5%, or 25 mL of s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram;Blood pressure;Physical examination; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital of Central South University
Outcome results
None listed