NCT03826901已完成1 期
A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
详细描述
A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1: adults and adolescents (12 years and above)
Experimental
Delgocitinib cream (dosage: A mg/g).
干预措施: delgocitinib (Drug)
Part 2: children (2-11 years)
Experimental
Delgocitinib cream (dosage: B mg/g).
干预措施: delgocitinib (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Week 0 to Week 8
Number of AEs and number of subjects with AEs
次要结局
- PK parameter - Cmax(at Day 8)
- PK parameter - AUC(at Day 8)
- PK parameter - tmax(at Day 8)
研究者
研究点 (1)
Loading locations...
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