[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632855":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":35,"collaborators":11,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":11,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":11,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":11,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"CSPC Ouyi Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"SYH9089 injection","EXPERIMENTAL",null,[13],"Drug: SYH9089 injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Ropivacaine hydrochloride","ACTIVE_COMPARATOR",[18],"Drug: Ropivacaine hydrochloride",{"label":20,"type":21,"description":11,"interventionNames":22},"0.9 % sodium chloride","PLACEBO_COMPARATOR",[23],"Drug: 0.9 % sodium chloride",[25,29,32],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","Before the surgical incision was closed, SYH9089 injection was applied to the incision wound.",[9],{"type":26,"name":15,"description":30,"armGroupLabels":31,"otherNames":11},"Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound, and a total of 20mL was given.",[15],{"type":26,"name":20,"description":33,"armGroupLabels":34,"otherNames":11},"Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.",[20],{"type":36,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632855","phase-1-study-evaluating-the-safety-efficacy-and-pharmacokinetics-of-syh9089-injection-in-patients-undergoing-abdominal-surgery-100632855",false,"NCT07519109","Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Undergoing Abdominal Surgery.","A Multicenter, Randomized, Double-Blind, Active Drug and Placebo Parallel-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety , Pharmacokinetics, and Efficacy of SYH9089 Injection in Patients Undergoing Abdominal Surgery","Inclusion Criteria:\n\n* 1\\. Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent, and voluntarily abide by the process of this study; 2. 18 years old ≤ age ≤75 years old, regardless of gender; 3. 19.0kg\u002Fm2≤BMI≤28.0kg\u002Fm2, ≥50.0kg for men and ≥45.0kg for women; 4. American Society of Anesthesiologists (ASA) grade I-II; 5. Elective abdominal surgery under general anesthesia, and the anticipated surgical incision is approximately 8-10 cm (inclusive), including at least one single incision of ≥ 5 cm in length; 6. Can understand the research process and the use of various scales involved in this study, and can effectively communicate with researchers.\n\nExclusion Criteria:\n\n* 1\\. Patients with a history of hypersensitivity to the investigational drug, comparator drug, surgical anesthetics, rescue analgesic drugs, or other drugs that may be used during the trial; 2. Patients with a history of drug abuse\u002Fsubstance use, or those with positive results on a drug abuse screening; 3. Patients with neurological\u002Fpsychiatric, respiratory, endocrine, hematologic, musculoskeletal, gastrointestinal, cardiovascular systems, or hepatic\u002Frenal diseases, judged by the investigator to be unsuitable for the trial; 4. Patients with a history of diabetes mellitus; 5. Patients with a history of myocardial infarction or unstable angina within 1 year prior to randomization; 6. Patients scheduled to undergo purely diagnostic exploratory surgery or palliative tumor resection, judged by the investigator to be unsuitable for the trial; 7. Patients with advanced malignant tumors with extensive metastasis during the screening period, judged by the investigator to be unsuitable for the trial; 8. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator; 9. Patients with a history of severe or refractory postoperative nausea or vomiting; 10. Use of the following drugs for less than 5 half-lives before randomization (based on the actual drug instructions; or within 7 days prior to randomization if the half-life is unclear) which, in the investigator's judgement, may affect the evaluation of analgesic efficacy. These include, but are not limited to: narcotics (opioids), local anesthetics, non-steroidal anti-inflammatory drugs (NSAIDs), sedative-hypnotics, non-benzodiazepines, sedative anesthetics, glucocorticoids (except for topical use), antiepileptics, anxiolytics, antidepressants, as well as Chinese herbal medicines or proprietary Chinese medicines with sedative or analgesic effects; 11. Use of strong CYP1A2 inhibitors for less than 5 half-lives before randomization (e.g., atazanavir, ciprofloxacin, enoxacin, fluvoxamine, ethinylestradiol) ； 12. Subjects with abnormal findings during the screening period (prior to admission) in vital signs, physical examination, 12-lead ECG, or laboratory tests, which in the investigator's judgement make the subject unsuitable for participation in this trial, including:\n\n  1. Patientss with poorly controlled blood pressure despite medication: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg; or systolic blood pressure \\\u003C90 mmHg;\n  2. 12-lead ECG: QTcF ≥450 ms for males or ≥470 ms for females, or a history of severe arrhythmias such as second-degree type II or higher atrioventricular block, or a history of cardiac insufficiency;\n  3. Coagulation function: PT \\> ULN + 3 seconds and\u002For APTT \\> ULN + 10 seconds;\n  4. Liver function: ALT and\u002For AST ≥ 2 × ULN; TBIL ≥ 1.5 × ULN; ALB \\\u003C 30 g\u002FL;\n  5. Renal function: Cr ≥ 1.5 × ULN;\n  6. PLT \\\u003C 80 × 10\\^9\u002FL;\n  7. HGB \\\u003C 90 g\u002FL;\n  8. Random blood glucose \\> 11.1 mmol\u002FL. 13. Positive for HBsAg, HCV-Ab, HIV-Ab, or TP-Ab;; 14. Female subjects with a positive pregnancy test or who are breast feeding; fertile subjects who plan to become pregnant, are unwilling or unable to use effective contraception during the trial and within 3 months after administration, or who plan to donate sperm or ova; 15. Patients with a history of drug abuse, substance use, and\u002For alcoholism within 6 months prior to randomization, (alcoholism is defined as alcohol consumption exceeding 14 units per week:1 unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine); 16. Patients who underwent major surgery within 3 months prior to randomization, or surgery that may significantly affect the in vivo metabolism of the investigational product or the evaluation of safety; 17. Patients with blood loss or blood donation exceeding 400 mL, or who received blood transfusion or blood products within 3 months prior to randomization; 18. Patients who participated in any clinical trial of drugs or medical devices within 3 months prior to randomization; 19. Any other conditions judged by the investigator to be unsuitable for participation in this trial.","ALL","18 Years","75 Years",{"count":48,"type":49},60,"ESTIMATED","INTERVENTIONAL",[52],"PHASE1","This is a randomized, double-blind, active drug- and placebo-controlled, dose-escalation clinical study conducted in patients scheduled to undergo abdominal surgery. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of SYH9089 Injection for postoperative analgesia in these patients.",[55],"Postoperative Pain","NOT_YET_RECRUITING","2026-04-02",{"date":59,"type":60},"2026-04-09","ACTUAL",{"date":62,"type":49},"2026-03-31",{"date":64,"type":49},"2027-03-31",{"name":5,"class":6}]