NCT07519109招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adverse Event Profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •18 years old ≤ age ≤75 years old, regardless of gender;
- •19.0kg/m2≤BMI≤28.0kg/m2, ≥50.0kg for men and ≥45.0kg for women;
- •American Society of Anesthesiologists (ASA) grade I-II;
- •Elective abdominal surgery under general anesthesia, and the length of the main incision is expected to be between 5-9cm (including the boundary value at both ends);
- •Can understand the research process and the use of various scales involved in this study, and can effectively communicate with researchers.
排除标准
- •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;
- •Patients with a history of drug abuse/substance use, or those with positive results on a drug abuse screening;
- •Patients with neurological/psychiatric, respiratory, endocrine, hematologic, musculoskeletal, gastrointestinal, cardiovascular systems, or hepatic/renal diseases, judged by the investigator to be unsuitable for the trial;
- •Patients with a history of diabetes mellitus;
- •Patients with a history of myocardial infarction or unstable angina within 1 year prior to randomization;
- •Patients scheduled to undergo purely diagnostic exploratory surgery or palliative tumor resection, judged by the investigator to be unsuitable for the trial;
- •Patients with advanced malignant tumors, judged by the investigator to be unsuitable for the trial;
- •Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator;
- •Patients with a history of severe or refractory postoperative nausea or vomiting;
- •Patients scheduled to receive interventions (e.g., intraperitoneal hyperthermic chemotherapy, local/intraperitoneal chemoperfusion, or infrared therapy) during the observation period (randomization to 120h after administration) that may interfere with postoperative pain assessment
- •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;
- •Use of strong CYP1A2 inhibitors for less than 5 half-lives before randomization (e.g., atazanavir, ciprofloxacin, enoxacin, fluvoxamine, ethinylestradiol) ；
- •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:
- •Patientss with poorly controlled blood pressure despite medication: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; or systolic blood pressure <90 mmHg;
- •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;
- •Coagulation function: PT > ULN + 3 seconds and/or APTT > ULN + 10 seconds;
- •Liver function: ALT and/or AST ≥ 2 × ULN; TBIL ≥ 1.5 × ULN; ALB < 30 g/L;
- •Renal function: Cr ≥ 1.5 × ULN;
- •PLT < 80 × 10^9/L;
- •HGB < 90 g/L;
- •Random blood glucose > 11.1 mmol/L.
- •Positive for HBsAg, HCV-Ab, HIV-Ab, or TP-Ab;;
- •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;
- •Patients with a history of drug abuse, substance use, and/or 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);
- •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;
- •Patients with blood loss or blood donation exceeding 400 mL, or who received blood transfusion or blood products within 3 months prior to randomization;
- •Patients who participated in any clinical trial of drugs or medical devices within 3 months prior to randomization;
- •Any other conditions judged by the investigator to be unsuitable for participation in this trial.
研究组 & 干预措施
SYH9089 injection
Experimental
干预措施: SYH9089 injection (Drug)
Ropivacaine hydrochloride
Active Comparator
干预措施: Ropivacaine hydrochloride (Drug)
0.9 % sodium chloride
Placebo Comparator
干预措施: 0.9 % sodium chloride (Drug)
结局指标
主要结局
Adverse Event Profile
时间窗: 14 days
Participants with an Adverse Event through 14 days
次要结局
- Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores(0 to 120 hours)
- Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores(0 to 120 hours)
- Cumulative use of rescue analgesics during each period(0 to 120 hours)
- Proportion of participants not requiring rescue analgesia in each period(0 to 120 hours)
- Proportion of participants with an NRS-A score ≤ 1 at different time points.(0 to 120 hours)
- Proportion of participants with an NRS-R score ≤ 1 at different time points.(0 to 120 hours)
- Time of first morphine rescue analgesia(0 to 120 hours)
- Maximum pain score at each dressing change(0 to 72 hours)
- Participant's Analgesic Satisfaction Score(0 to 120 hours)
- Investigator Satisfaction Score(0 to 120 hours)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy ParticipantsNCT07419698Shanghai JMT-Bio Inc.44
Enrolling By Invitation
1 期
To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese SubjectsMajor Depressive DisorderNCT07371065Luye Pharma Group Ltd.98
招募中
1 期
A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple DosesObesityNCT07280936Beijing Suncadia Pharmaceuticals Co., Ltd124
招募中
2 期
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma PatientsAllergic AsthmaNCT07342803Longbio Pharma200
尚未招募
1 期
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..Cutaneous Lupus ErythematosusSystemic Lupus ErythematosusNCT07408908Xiamen Amoytop Biotech Co., Ltd.48