A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair
试验速览
- 阶段
- 1 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of SAEs and treatment-related severe AEs
研究概览
简要总结
Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To maintain objectiveness, the study drug will be managed and administered by an independent unblinded team. Subjects, investigators, and all other site staff who directly interact with subjects, evaluate safety and efficacy, and collect subject data, will remain blinded and must not communicate or discuss any study information with the unblinded team.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent 2、Male or female between 18 and 70 years of age 3、Scheduled to undergo a primary, inguinal hernia repair with mesh, and be able to use the anesthesia regimen 4、Meet the body mass 5、Conform to the ASA Physical Status Classification
排除标准
- •Clinically significant abnormal clinical laboratory test value
- •Subjects with poor blood pressure control after medication
- •Subjects with atrioventricular block or cardiac insufficiency
- •Subjects with a history of myocardial infarction or unstable angina pectoris
- •Subjects with a history of ischemic stroke or transient ischemic attack
- •Combination of other pain conditions that may affect postoperative pain assessment
- •Allergic to a drug ingredient or component
- •Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
- •History of alcohol abuse or prescription and/or illicit drug abuse within 1 years
- •Subjects with special diets (including tobacco, grapefruit and caffeine)
- •Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- •History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or hepatitis B.
- •Use of any of the following medications within 14 days or as specified prior to the study surgical procedure:
- •Have had an inguinal hernia repair in the last 3 months before the study surgical procedure or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with a large scrotal component that would be difficult to reduce surgically
- •Participated in clinical trials of other drugs (received experimental drugs)
- •History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •The inestigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
dose 1
HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
干预措施: HR18034 (Drug)
dose 2
HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
干预措施: HR18034 (Drug)
dose 3
HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
干预措施: HR18034 (Drug)
dose 4
HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
干预措施: HR18034 (Drug)
Naropin
Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial
干预措施: Naropin (Drug)
结局指标
主要结局
Number of SAEs and treatment-related severe AEs
时间窗: 14 days
Safety and tolerability:
次要结局
- Pain intensity assessed using an 11-point NPRS ranging(Baseline till 168 hours post IP administration)
- PK AUC(Baseline till 168 hours post IP administration)
- Proportion of subjects who used no rescue opioid analgesic(Baseline till 168 hours post IP administration)
- AUC of NPRS(For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours)
- Patient Global Assessment of the method of pain control(24 hours post IP administration till 168 hours post IP administration)
- Proportion of pain-free subjects at scheduled timepoints.(Baseline till 168 hours post IP administration)
- Average daily rescue analgesic consumption(Baseline till 168 hours post IP administration)
- PK Cmax(Baseline till 168 hours post IP administration)
- Wound assessment by Wound healing and status score(Day 1 through Day 14)
- Time to the first postoperative use of rescue opioid analgesics(Baseline till 168 hours post IP administration)