NCT07349381进行中（未招募）1 期
An Open-label, Randomized, Multiple-dose, Two-cycle, Two-way Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of CX11 Tablets in Healthy Participants
Vincentage Pharma Co., Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年3月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)
研究概览
简要总结
This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully understand the objective, nature, methods, and possible adverse reactions of the study; be able to communicate well with the investigator; voluntarily take part in the study and be willing to comply with the requirements of this study; and sign the informed consent form before all study procedures are started
- •Weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) is ≥ 20.0 kg/m2 and < 28 kg/m2 at the screening visit and on Day 21.
排除标准
- •Participants with allergic constitution or known previous history of allergy to CX11 or similar compounds and related excipients, or history of atopic allergic diseases
- •Participants who have experienced clinically significant acute diseases during the pre-study screening period or within 2 weeks prior to the first dose of the investigational product
- •Participants who have pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could affect drug absorption, distribution, metabolism, and/or excretion as judged by the investigator, or plan to receive any surgery during the study
- •Participants suffering from any clinically significant chronic diseases, including but not limited to disorders of the respiratory system, cardiovascular system, urinary system, blood system, endocrine system, and immune system, as well as the digestive system (e.g., history of or current fatty liver disease, including metabolic dysfunction-associated steatohepatitis
- •History of thyroid dysfunction requiring medication or with a thyroid stimulating hormone (TSH) level exceeding the normal reference range at screening or on Day 21
- •Participants who have been vaccinated within 30 days before the screening or plan to be vaccinated during the study
- •Participated in any other clinical study and received an investigational intervention within 90 days or 5 elimination half-lives (whichever is longer) of the investigational intervention, prior to screening
研究组 & 干预措施
Fasted-Fed Arm
Experimental
Fasted-Fed Group
干预措施: CX11 (VCT220) (Drug)
Fed-Fasted Arm
Experimental
Fed-Fasted Group
干预措施: CX11 (VCT220) (Drug)
结局指标
主要结局
Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)
时间窗: Predose at Day1 up to 35 days postdose
AUC0-24 of of CX11 (VCT220)
Maximum Observed Concentration (Cmax) of CX11 (VCT220)
时间窗: Predose at Day1 up to 35 days postdose
Cmax of CX11 (VCT220)
Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)
时间窗: Predose at D1 up to 35 days postdose
AUC0-24 of of CX11 (VCT220)
Maximum Observed Concentration (Cmax) of CX11 (VCT220)
时间窗: Predose at D1 up to 35 days postdose
Cmax of CX11 (VCT220)
Time to Maximum Observed Concentration (Tmax) of CX11 (VCT220)
时间窗: Predose at Day 1 up to 35 days postdose
Tmax of CX11 (VCT220)
次要结局
未报告次要终点
研究者
研究点 (1)
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