NCT01343186已完成1 期
A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Measuring interferon levels in blood samples
研究概览
简要总结
This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 subjects
- •Age between 18 and 45, inclusive
- •Body mass index(BMI)between 19 and 26, inclusive
- •Sign informed consent
排除标准
- •Women of pregnant or lactation
- •Known hypersensitivity to interferon or any other components of the study drug
- •History of mental disease or genetic disease
- •History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant
- •Significant disease in heart, liver, kidney, lung or any other major organs
- •Alcoholic, smokers or drug abusers
- •Blood donation, or massive blood loss due to injury or surgery within 3 months
- •Other conditions which in the opinion of the investigator preclude enrollment into the study
研究组 & 干预措施
Arm 1
Other
干预措施: Peginterferon alfa (Drug)
Arm 2
Other
干预措施: Peginterferon alfa 2a (Drug)
Arm 3
Other
干预措施: Peginterferon alfa-2a (Drug)
Arm 4
Other
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Measuring interferon levels in blood samples
时间窗: from 0 to 408 hours following injection
Different blood interferon biomarkers (such as 2,5-OAS, neopterin)
时间窗: from 0 to 408 hours following injection
次要结局
- Adverse events(up to 3 weeks following injection)
- Anti-interferon antibody(baseline and week 2 after injection)
研究者
研究点 (1)
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