Acute pain
Conditions
Interventions
Part 1: 5 mg dose group (2 cases in treatment group, 1 case in placebo group):On the morning of the dosing day, subjects received an intravenous infusion of 5 mg KR25102 for Injection or placebo via a
Part 1: 10 mg dose group (8 cases in treatment group, 2 case in placebo group):On the morning of the dosing day, subjects received an intravenous infusion of 10 mg KR25102 for Injection or placebo via
Part 1: 20 mg dose group (8 cases in treatment group, 2 case in placebo group):On the morning of the dosing day, subjects received an intravenous infusion of 20 mg KR25102 for Injection or placebo via
Part 1 30mg dose group (8 cases in treatment group, 2 case in placebo group):On the morning of the dosing day, subjects received an intravenous infusion of 30 mg KR25102 for Injection or placebo via a
Part 1 45mg dose group (8 cases in treatment group, 2 case in placebo group):On the morning of the dosing day, subjects received an intravenous infusion of 45 mg KR25102 for Injection or placebo via a
Part 1 60mg dose group (8 cases in treatment group, 2 case in placebo group):On the morning of the dosing day, subjects received an intravenous infusion of 60 mg KR25102 for Injection or placebo via a
Part 2 10mg once daily (8 cases in treatment group, 2 case in placebo group):On the morning of each dosing day
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18 to 55 years old (inclusive) at the time of signing the informed consent form; 2. Male participants weighing >=50 kg and female participants weighing >=45 kg, with a body mass index (BMI) between 19 and 26 kg/m^2 (inclusive); 3. Participants and their partners do not plan to conceive, donate sperm, or donate eggs from the time of signing the informed consent form until 2 months after the last administration of the study drug, and voluntarily agree to use effective contraception; 4. Female participants: not pregnant or breastfeeding; women of childbearing potential must undergo serum pregnancy tests during the screening and baseline periods, with negative results; 5. For groups requiring pain testing: willing to undergo pain tests and properly trained; and the skin at the site of pain stimulation has no wounds or dermatological conditions. 6. Participants fully understand the purpose and requirements of this trial, are aware of the potential risks, are willing to strictly comply with all trial requirements, voluntarily participate in the clinical trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have had or currently have any of the following diseases, including but not limited to diseases of the cardiovascular system, endocrine and metabolic systems, neuropsychiatric system, digestive system, respiratory system, blood and lymphatic system, immune system, urinary system, musculoskeletal system, and malignant tumors, as well as other acute and chronic clinical diseases, and deemed unsuitable for enrollment by the investigator; 2. Have a personal or family history of hereditary angioedema; 3. Known allergy to the investigational drug or any component of the investigational drug, history of chronic urticaria, severe allergic reactions, or atopic constitution (allergic to two or more drugs and foods); 4. Unable to tolerate intravenous administration, have difficulty with venous blood collection, or a history of fainting at the sight of needles or blood; 5. Underwent major surgery within 6 months prior to screening, or planning to undergo surgery during the trial; 6. Taken any medication or health supplements (including herbal medicine) within 14 days prior to administration, or known during the screening period to potentially require other medication during the trial; 7. Used any liver enzyme inhibitors/inducers within 1 month prior to administration (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John’s wort, etc.); 8. Participated in any clinical trial and used any investigational drug/device within 3 months prior to screening, or plan to participate in another clinical trial during the study; 9. Donated blood or lost >=200 mL of blood (excluding menstrual blood loss in women), received a blood transfusion, or used blood products within 6 months prior to screening, or plan to donate blood during the trial or within 1 month after trial completion; 10. Consumed excessive tea (>15g of tea leaves/day; generally 3–5 g per brew), coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 200 mL) daily within 3 months prior to screening, or unable to stop consuming tea, coffee, and/or caffeine-rich beverages during the trial, or consumed special foods (e.g., grapefruit, grapefruit juice, or foods/drinks containing grapefruit juice) within 2 days prior to administration or unable to stop during hospitalization, or other special diets affecting drug absorption, distribution, metabolism, or excretion; 11. Smokers: averaged more than 5 cigarettes per day within 3 months prior to screening, or unable to quit smoking during the trial; drinkers: positive on alcohol breath test, or averaged more than 14 units of alcohol per week within 3 months prior to screening (1 unit ˜ 285 mL beer with 3.5% alcohol, 25 mL spirits with 40% alcohol, or 85 mL wine with 12% alcohol), or unable to abstain from alcohol during the trial; 12. History of substance abuse or positive substance abuse screening; 13. Physical examination results during the screening or baseline period deemed clinically significant abnormalities by the study physician; 14. Individuals who test positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum (syphilis) antibody screening; 15. Individuals with heart disease, including but not limited to congenital long QT syndrome, torsades de pointes, or risk factors for torsades de pointes (such as heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs;12-lead ECG indicators;Ambulatory electrocardiogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic;Cold pain detection threshold;Heat pain detection threshold;Pain tolerance time; | — |
Countries
China
Contacts
Public ContactYang Guoping
Xiangya Third Hospital of Central South University
Outcome results
None listed