NCT01244607已完成1 期
A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis
Light Chain Bioscience - Novimmune SA0 个研究点目标入组 22 人开始时间: 2010年11月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Effect of NI-0801 administration on the severity of the cutaneous response to Nickel challenge as measured using the score system of the DKG (Deutsche Kontakt-Allergie Gruppe).
研究概览
简要总结
The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 and ≤ 70 years
- •Either male or a female lacking childbearing potential
- •Previously documented nickel allergy
排除标准
- •Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
- •Known or previous diagnosis of malignancy
- •Known current active tuberculosis or a history of active TB within 12 months of screening
- •Known infection with HIV, Hepatitis B or C
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
NI-0801
Experimental
干预措施: NI-0801 (Drug)
结局指标
主要结局
Effect of NI-0801 administration on the severity of the cutaneous response to Nickel challenge as measured using the score system of the DKG (Deutsche Kontakt-Allergie Gruppe).
次要结局
- Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.
研究者
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