[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632855":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":58,"interventions":74,"overallOfficials":46,"centralContacts":46,"locations":46,"responsibleParty":85,"collaborators":46,"id":87,"slug":46,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":46,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":46,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":46,"overallStatus":105,"whyStopped":46,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":46},{"fullName":5,"class":6},"CSPC Ouyi Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse Event Profile","Participants with an Adverse Event through 14 days","14 days",[14,18,21,24,27,30,33,36,40,43],{"measure":15,"description":16,"timeFrame":17},"Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores","The AUC of NRS-R during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.","0 to 120 hours",{"measure":19,"description":20,"timeFrame":17},"Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores","The AUC of NRS-A during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.",{"measure":22,"description":23,"timeFrame":17},"Cumulative use of rescue analgesics during each period","Cumulative amount of rescue analgesics used during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration.",{"measure":25,"description":26,"timeFrame":17},"Proportion of participants not requiring rescue analgesia in each period","Proportion of participants not requiring rescue analgesia within 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration.",{"measure":28,"description":29,"timeFrame":17},"Proportion of participants with an NRS-A score ≤ 1 at different time points.","Proportion of participants with an NRS-A score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.",{"measure":31,"description":32,"timeFrame":17},"Proportion of participants with an NRS-R score ≤ 1 at different time points.","Proportion of participants with an NRS-R score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.",{"measure":34,"description":35,"timeFrame":17},"Time of first morphine rescue analgesia","The time from administration to the first morphine rescue analgesic treatment",{"measure":37,"description":38,"timeFrame":39},"Maximum pain score at each dressing change","Maximum pain score at each dressing change at 24 h, 48 h, and 72 h after administration.","0 to 72 hours",{"measure":41,"description":42,"timeFrame":17},"Participant's Analgesic Satisfaction Score","Participant satisfaction will be assessed at 120 hours after administration.",{"measure":44,"description":45,"timeFrame":17},"Investigator Satisfaction Score","Investigator satisfaction will be assessed at 120 hours after administration",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":46,"timePerspective":46,"maskingInfo":52},"RANDOMIZED","PARALLEL","This is a randomized, double-blind, parallel-group, dose-escalation study. Sixty subjects scheduled for abdominal surgery will be enrolled and equally allocated to 5 dose groups (12 subjects per group). Within each group, subjects will be randomly assigned in a 4:1:1 ratio to receive SYH9089, active comparator, or placebo.","TREATMENT",{"masking":53,"maskingDescription":46,"whoMasked":54},"TRIPLE",[55,56,57],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[59,64,69],{"label":60,"type":61,"description":46,"interventionNames":62},"SYH9089 injection","EXPERIMENTAL",[63],"Drug: SYH9089 injection",{"label":65,"type":66,"description":46,"interventionNames":67},"Ropivacaine hydrochloride","ACTIVE_COMPARATOR",[68],"Drug: Ropivacaine hydrochloride",{"label":70,"type":71,"description":46,"interventionNames":72},"0.9 % sodium chloride","PLACEBO_COMPARATOR",[73],"Drug: 0.9 % sodium chloride",[75,79,82],{"type":76,"name":60,"description":77,"armGroupLabels":78,"otherNames":46},"DRUG","Before the surgical incision was closed, SYH9089 injection was applied to the incision wound.",[60],{"type":76,"name":65,"description":80,"armGroupLabels":81,"otherNames":46},"Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound, and a total of 20mL was given.",[65],{"type":76,"name":70,"description":83,"armGroupLabels":84,"otherNames":46},"Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.",[70],{"type":86,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","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":97,"type":98},60,"ESTIMATED","INTERVENTIONAL",[101],"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.",[104],"Postoperative Pain","NOT_YET_RECRUITING","2026-04-02",{"date":108,"type":109},"2026-04-09","ACTUAL",{"date":111,"type":98},"2026-03-31",{"date":113,"type":98},"2027-03-31",{"name":5,"class":6}]