NCT07277933尚未招募1 期
Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Patients: A Randomized, Double-blind, Placebo-Controlled, Phase Ib Trial
Chengdu Kanghong Pharmaceutical Group Co., Ltd.0 个研究点目标入组 24 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. To preliminarily evaluate the safety and efficacy of KHN702 tablets in moderate to severe post-operative pain 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, Care Provider, Investigator)
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
- •Subjects between the ages of 18 and 75 years, inclusive.
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- •Patients scheduled for surgery.
- •According to the researcher's medical judgment, American Society of Anesthesiologists (ASA) classification≤Grade II.
- •The subject can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures.
- •NRS ≥ 4 points within 6 hours after surgery.
排除标准
- •Participants experiencing acute or chronic pain unrelated to the surgical site, which the investigator deems may confound the participant's assessment of postoperative pain.
- •History or evidence of any of the following conditions prior to screening:
- •History of significant cardiovascular or cerebrovascular disease;
- •Severe respiratory disease history;
- •Severe Neurological and Psychiatric disease History;
- •Active peptic ulcer disease, significant vomiting, chronic diarrhea, ileus, malabsorption, or other known conditions that significantly affect drug absorption, distribution, metabolism, or excretion;
- •Subjects at high risk of bleeding who are deemed unsuitable for this trial by the investigator;
- •Long-term use of opioids or nonsteroidal anti-inflammatory drugs within the past 30 days prior to screening, or discontinuation of medications affecting analgesic efficacy assessment (except those permitted by the protocol) less than 5 half-life prior to randomization.
- •Subjects with a history of opioid allergy, or those with a history of allergy to the intraoperative medications specified in the protocol, postoperative rescue analgesics, or known allergies to the investigational drug or its excipients.
- •Subjects who underwent major surgery within 3 months prior to screening and the investigator determined that it would affect postoperative pain assessment.
- •Any of the following infectious diseases were present during screening: Hepatitis B surface antigen (HBsAg) positive, hepatitis C virus antibody (HCV Ab) positive, human immunodeficiency virus antibody (HIV Ab) positive, or serum treponema pallidum antibody (TPAb) positive.
- •History of substance abuse or alcohol abuse within the three months prior to screening .
- •History of blood donation within the past three months prior to screening.
- •Individuals who have participated in any clinical research within the past three months prior to screening .
- •Pregnant or lactating women; women or men of reproductive potential who are unwilling to use contraception throughout the study period; or subjects (including male subjects) planning to conceive within 3 months after study completion.
- •Subjects with intraoperative blood loss exceeding 1000 mL or those experiencing other severe complications during surgery;
- •Subjects requiring intensive care following surgery;
- •Other circumstances deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
KHN702
Experimental
Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days.
干预措施: KHN702 (Drug)
KHN702 placebo
Placebo Comparator
Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days.
干预措施: KHN702 placebo (Drug)
结局指标
主要结局
Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose
时间窗: 48 hours
次要结局
- Safety：Incidence and severity of Adverse Events( AE)/SAE(from ICF signing date to day 7 since the first dose)
- Cmax(48 hours)
- Time-weighted the Sum of Pain Intensity Differences in Pain Score over Times(48 hours)
- Times and Cumulative Amount of Rescue Analgesics Used by Subjects within 0 to 48 Hours after the First Dose.(48 hours)
- Tmax(48 hours)
- AUC0-t(48 hours)
研究者
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