NCT03383276Unknown1 期
A Phase 1, Dose Escalating Study of the Safety, Tolerability, and Pharmacokinetics of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年12月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Measurement of intraocularpressure
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of ocular administration of Topical Interleukin-1-Receptor Antagonist in healthy volunteers. Additionally, the PK of Interleukin-1-Receptor Antagonist will be assessed.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and/or females between the ages of 18 and 45 years
- •Medically healthy
- •Best correction vision of greater than or equal to 20/20 in each eye
- •BMI ≥ 19 and < 24 kg/m2
- •Ability to understand and provide informed consent to participate in this study
- •Willingness to follow study instructions and likely to complete all required visits
排除标准
- •Any ocular or systemic diseases
- •History of skin or ocular allergy symptoms
- •Use contact lenses during the trails.
- •Taking inhaled or oral steroids (for example Advair, Orapred)
- •Have an active infection
- •Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
- •Receipt of any blood or blood products within 2 months prior to the first dosing day.
- •Use any drugs within 2 weeks prior to the first dosing day.
- •Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication or experimental drug within the past 4 weeks.
- •Have been exposed to an investigational drug/device within the preceding 3 months
- •Pregnant or lactating females
- •History of substance abuse, drug addiction or alcoholism
- •Males and females unwilling to use an acceptable method of contraception for the duration of the study
研究组 & 干预措施
IL-1Ra
Experimental
干预措施: IL-1Ra (Drug)
结局指标
主要结局
Measurement of intraocularpressure
时间窗: 3 days
Slit lamp examination
时间窗: 3 days
Corneal fluorescein staining
时间窗: 3 days
Best corrected visual acuity
时间窗: 3 days
Ocular symptomatology
时间窗: 3 days
次要结局
- ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.(3 days)
研究者
研究点 (1)
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