NCT07762443尚未招募1 期
A Phase I Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata
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
- 24
- 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, dose-finding Phase I study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with severe alopecia areata (AA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 ≥ 40 kg.
- •Subjects must meet the diagnostic criteria for alopecia areata (AA) at both screening and baseline visits.
排除标准
- •Women who are pregnant or breastfeeding, or subjects who plan to become pregnant or breastfeed during the study period.
- •Subjects with a current diagnosis of acute diffuse alopecia areata (AA).
- •Subjects with a current diagnosis of other types of alopecia that may interfere with the evaluation of AA, including but not limited to traction alopecia, cicatricial alopecia, telogen effluvium, androgenetic alopecia, syphilitic alopecia, anagen effluvium, folliculotropic mycosis fungoides, or alopecia caused by thyroid disease, etc.
- •Subjects with other scalp diseases that may affect the assessment of AA, such as scalp psoriasis, dermatitis, tinea capitis, etc.
研究组 & 干预措施
VC005 Tablets Low Dose groups
Experimental
干预措施: VC005 tablets (Drug)
VC005 Tablets High Dose groups
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)
Loading locations...
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