QT Interval Effects Study of Oral FXS5626 Tablets
A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and QT Interval Effects of Oral FXS5626 Tablets in Healthy Chinese Participants
The purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects.
研究概览
研究类型
介入性
注册 (估计的)
28
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Wei Xue, PHD
- 电话号码:86 010-58115037
- 邮箱:roserebel@126.com
研究联系人备份
- 姓名:Wenyuan Qi
- 电话号码:86 010-85138673
- 邮箱:qiwenyuan.bjhmoh@gmail.com
学习地点
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100730
- Beijing Hospital
-
接触:
- Qingqing Wang
- 电话号码:86 010-58115037
- 邮箱:bjyygcp@vip.126.com
-
接触:
- Haijuan Zhao
- 电话号码:86 010-85138673
- 邮箱:bjyygcp@vip.126.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Healthy, adult, male or female,18-45 years of age (inclusive), with a Body Mass Index (BMI) of 19.0-28.0 kg/m2 (inclusive),have a minimum weight of at least 50kg(male) or 45kg(female).
- Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Female subjects of childbearing potential and male subjects with a partner of childbearing potential who voluntarily signed ICF should be no fertile, sperm/egg donation for 3 months from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).
Exclusive Criteria:
- Female subjects who are pregnant,or breastfeeding,or with a positive pregnancy test
- Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.
- Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.
- Subjects who have a history of other risk factors for tachycardia, or a family history of a first-degree relative (i.e. biological parent, sibling, or child) of short QT syndrome, long QT syndrome, or sudden unexplained death in young age (≤40 years).
- Significant screening ECG abnormalities,QTcF interval > 450ms (Fridericia's correction), or QRS>120ms,or PR interval >=210ms or <=120ms
- Subjects who have got severe infections within 2 months before screening; Or have a history of active bacterial infection or viral infection or fungal infection within 2 weeks before screening
- Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.
- Subjects with a history of drug abuse,or who screened positive for drug abuse.
- Subjects who consumed more than 14 units of alcohol per week in the 6 months prior before screening (1 unit of alcohol =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or had a positive alcohol breath test or could not abstain during the trial.
- Subjects who smoked more than 5 cigarettes per day in the 6 months prior before screening or could not give up during the trial.
- Subjects who have abnormal laboratory test: neutrophil count<1.5 x10^9/L,or white blood cell count<3.5 x10^9/L,or creatine kinase greater than the upper limit of normal at screening.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:FXS5626
FXS5626 75mg、250mg、400mg; single dose, oral
|
FXS5626 75mg、250mg、400mg, single dose, oral
|
|
安慰剂比较:Placebo
single dose, oral
|
single dose, oral
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effect on QTcF between baseline and post-dose treatment of FXS5626
大体时间:45 min before administration and 24 hours after administration
|
The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
|
45 min before administration and 24 hours after administration
|
|
To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of single ascending oral dose of FXS5626 in healthy adults.
大体时间:Approximately 1 week
|
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests
|
Approximately 1 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plasma concentration and pharmacokinetic parameters
大体时间:10 min before administration and 48 hours after administration
|
Cmax
|
10 min before administration and 48 hours after administration
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月5日
初级完成 (估计的)
2026年9月25日
研究完成 (估计的)
2026年9月25日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月6日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- FXS5626-104
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.