A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of KH607 in Healthy Chinese Participants
2026年6月8日 更新者:Chengdu Kanghong Pharmaceutical Group Co., Ltd.
A Randomized, Open-Label, 2-period, 2-sequence, Crossover Food-Effect Study of KH607 Tablets in Healthy Chinese Participants
This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.
研究概览
研究类型
介入性
注册 (估计的)
16
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:Chang Meng Yang, Medical Doctor
- 电话号码:86-28-87393401
- 邮箱:ymc681@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:
- Participants must be healthy and aged ≥18 and <45 years at the time of screening visit.
- Participants must have a body weight equal to or greater than 50 kg (≧45 kg for females ) and a body mass index between 19.0 kg/m2 and 28.0 kg/m2 at the time of screening visit.
- Participants who have no plans for reproduction during the study period and for 3 months following the last dose, must voluntarily agree to use effective and appropriate contraceptive measures, and must have no plans for sperm or egg donation during this period.
- Participant who can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures shall be included
Exclusion Criteria:
- Participants with known allergy to any ingredient of KH607; or those with a known history of allergy to drugs of the same class; or those with known allergies to two or more other drugs, foods, or environmental factors; or those known to be prone to allergic symptoms such as rash, urticaria, etc. shall be excluded.
- Participants with diseases of the cardiovascular, nervous, respiratory, urinary, digestive, hematologic, endocrine, or immune systems, or psychiatric disorders (including but not limited to: history of epilepsy, Parkinson's disease or other movement disorders, clinically significant history of syncope or vertigo, and any history of psychiatric disorders), which may affect the safety evaluation of the trial, and who, in the opinion of the investigator, are unsuitable for participation in the trial.
- Participants with a history of vestibular dysfunction or severe motion sickness; or a history of ocular disorders such as glaucoma, retinopathy, or other ophthalmic diseases that may cause blurred vision or exacerbate visual adverse effects and are considered clinically significant by the investigator shall be excluded.
- Participants who are unable to Irefrain from driving vehicles, operating hazardous machinery, or working at heights from the time of signing the informed consent form until 1 week after the last dose shall be excluded.
- Participation who have participated in another clinical trial and received an investigational drug, vaccine, or device within 90 days prior to the first dose shall be excluded.
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:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Sequence A: KH607
period 1: Fasted, Period 2: Fed
|
KH607, single dose, oral
|
|
实验性的:Sequence B: KH607
period 1: Fed, Period 2: Fasted
|
KH607, single dose, oral
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
AUC0-t
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
AUC0-∞
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
Cmax
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
The GMRs and their 90% confidence intervals for AUC0-∞ (or AUC0-t and Cₘₐₓ of KH607 tablets under fasting and fed conditions )
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Tmax
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
t1/2
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
λz
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
tlag
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
CL/F
大体时间:Up to 96 Hours after study drug administration
|
Up to 96 Hours after study drug administration
|
|
Safety:Incidence and severity of Adverse Events ( AE)/SAE
大体时间:from ICF signing date to day 19 since first dose
|
from ICF signing date to day 19 since first dose
|
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6月1日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年7月1日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月9日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- KH607-30104
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
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.