NCT07329101已完成1 期
Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VC005 in Adolescent Subjects With Mild to Moderate Atopic Dermatitis
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
研究概览
简要总结
This is a single arm, and open-label phase I study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •When giving informed consent, the age range is 12-18 years old (including 12 years old), with no gender restrictions;
- •The subjects and their guardians voluntarily sign an informed consent form (dated), indicating that the subjects have been informed of all relevant parts of the study;
- •All women and all men with the potential to conceive must be willing to use at least one highly effective method of contraception from the time of signing the informed consent form until 3 months after the last administration of the investigational drug
排除标准
- •Subjects suspected to be allergic to VC005 gel or to excipients in VC005 gel, or with ≥ 2 kinds of drug allergy history in the past;
- •The researchers believe that there may be skin injuries or abnormalities in the subjects that could affect the evaluation of the administration site of the investigational drug；
- •The researchers believe that the subjects have clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of the administration site, including but not limited to psoriasis, acne, dysplastic nevi, and skin cancer;
研究组 & 干预措施
VC005
Experimental
干预措施: VC005 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
时间窗: Day1，Day28
Peak Plasma Concentration (Cmax）
时间窗: Day1，Day28
次要结局
未报告次要终点
研究者
研究点 (1)
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