NCT07828639尚未招募1 期
A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of VC005 Tablets in Adolescent Subjects With Non-Segmental Vitiligo
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 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 study is a multicenter, open-label, non-randomized study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with Non-Segmental Vitiligo
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
- •The subject fully understands this study and is able to comply with the relevant trial procedures. The subject and their legal guardian voluntarily sign the informed consent form (ICF).
- •Age 12 to 18 years inclusive (including 12 years old, excluding 18 years old) at the time of signing the ICF, both genders, with body weight ≥ 30 kg.
- •Subjects with a clinical diagnosis of non-segmental vitiligo
排除标准
- •Pregnant or breastfeeding women, or subjects planning to become pregnant or breastfeed during the study period.
- •Trial participants with complete depigmentation of hair within the vitiligo area.
- •Trial participants clinically diagnosed with segmental vitiligo, mucosal non-segmental vitiligo, or other cutaneous depigmentation disorders.
研究组 & 干预措施
VC005 Tablets
Experimental
干预措施: VC005 tablets (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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