A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱa Study to Evaluate the Safety and Efficacy of HL-1186 Tablets for Postoperative Pain Management in Abdominal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SPID48
研究概览
简要总结
This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for postoperative pain management in abdominal surgery.
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
- Quadruple (Participant, Care Provider, 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
- •18 years old ≤ age ≤ 75 years old, gender is not limited.
- •18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m
- •Scheduled to undergo abdominal surgeries under general anesthesia.
- •Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
排除标准
- •Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
- •Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
- •Unstable angina, myocardial infarction, severe arrhythmias (e.g., third-degree atrioventricular block), New York Heart Association (NYHA) class III or higher cardiac function, recurrent asthma, etc., within screen period, and deemed ineligible per investigator's judgments.
- •High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet function abnormalities), active bleeding, etc., and deemed ineligible per investigator's judgments.
- •For female participants: Pregnant or lactating (within 1 year postpartum).
- •Participants with childbearing potential planning conception/sperm/egg donation within 6 months post-treatment, or unwilling to use effective contraception (abstinence, barrier methods, oral contraceptives, intrauterine device, or sterilization).
- •Judgment by the investigator that the participant should not enter the study due to other conditions.
研究组 & 干预措施
HL-1186
Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses
干预措施: HL-1186 (Drug)
HL-1186 placebo
Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses
干预措施: HL-1186 placebo (Drug)
结局指标
主要结局
SPID48
时间窗: 0 to 48 hours
SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Day 1 to Day 30)