NCT06742840已完成1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-2129 Following Multiple Doses Administration in Healthy Subjects
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events (AEs)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-2129 in healthy subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 55 years old (inclusive);
- •Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 ~ 28.0 kg/m2 (inclusive);
- •Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose;
- •Female subjects: non-pregnant or non-lactating;
- •The skin to receive pain stimuli has no wound or derma disease;
- •Subject who is willing to accept pain test;
- •Subject who voluntarily signs the informed consent.
排除标准
- •Subject who suffers from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities;
- •Subject with a history of torsade de pointes, symptomatic or multigenic or frequent or require medical treatment arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;
- •Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution;
- •Subject who underwent major surgery within 6 months prior to screening, or received surgery that may significantly affect the pharmacokinetics or safety evaluation of the IMP, or who plans to undergo surgery during the study period;
- •Subject with a medication history that inhibits or induces liver metabolism of drug has been used within 1 month before administration;
- •Subject with vaccinated within 1 month prior to screening or plan to be vaccinated during the study;
- •Subject who used any drugs or health products (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or who plans to receive other drug treatments during the study;
- •Subject who has participated in clinical trials and received experimental drugs within 3 months before screening, or plans to participate in other clinical trials during this study;
- •Donate blood/blood loss ≥ 400 mL within 3 months before screening;
- •Subject who smoked more than 5 cigarettes per day on average within 3 months before screening;
- •Drink more than 14 units of alcohol per week on average;
- •Drink excessive tea, coffee or caffeinated beverages within 3 months before screening;
- •Consume special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before administration;
- •Subject who has special requirements for diet and cannot follow a unified diet;
- •Subject with clinical significant abnormalities in medical examination;
- •Subject with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody;
- •Subject with a history of drug abuse or with a positive result for drug abuse test;
- •Alcohol test result is positive;
- •Subject who has difficulty in swallowing, or venous blood collection, or who cannot tolerate venipuncture, or who has a history of fainting of needle or blood;
- •Subject who is judged to have suicidal ideation or suicidal behavior by mental state assessment;
- •Subject may not be able to complete the study due to other reasons or the investigators considers that he is not suitable for inclusion.
研究组 & 干预措施
HRS-2129 placebo group
Placebo Comparator
干预措施: HRS-2129 placebo (Drug)
HRS-2129 experimental group
Experimental
干预措施: HRS-2129 (Drug)
结局指标
主要结局
The incidence and severity of adverse events (AEs)
时间窗: From ICF signing date to Day 41.
次要结局
- Cold Pain detection threshold for the Thermode Cold Test(Day 1 to Day 15.)
- Heat Pain detection threshold for the Thermode Heat Test(Day 1 to Day 15.)
- Pain tolerance time for the Cold Pain Test(Day 1 to Day 15.)
- Number of participants with clinically meaningful findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses(From ICF signing date to Day 15.)
- Time to reach maximum plasma concentration (Tmax) of HRS-2129(0 hour to 216 hours after administration.)
- Terminal half-life (t1/2)(0 hour to 216 hours after administration.)
- Maximum plasma concentration (Cmax) of HRS-2129(0 hour to 216 hours after administration.)
- Apparent clearance (CL/F) of HRS-2129(0 hour to 216 hours after administration.)
- Apparent volume of distribution (Vz/F) of HRS-2129(0 hour to 216 hours after administration.)
研究者
研究点 (1)
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