NCT01119677已完成1 期
A Randomized, Three-Arm, Dose-Blinded, Parallel-Group Study to Determine the Effect of Avonex® Dose Titration on the Severity and Incidence of Interferon Beta-1a-Related Flu Like Symptoms in Healthy Volunteers
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
- Biogen
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To determine whether titration of Avonex reduces the incidence of flu like symptoms
研究概览
简要总结
The primary objective of the study is to determine whether titration of Avonex reduces the severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety and tolerability of Avonex intramuscular (IM) injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening.
- •Female participants of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb])
- •Known history of chronic fatigue syndrome or fibromyalgia
- •Within one month, flu-like illnesses (e.g., gastroenteritis, upper respiratory infection, common cold)
- •History of severe allergic reactions to any drug or anaphylactic reactions
- •Known allergy to Avonex or any of its components
- •Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to Screening or active bacterial or viral infection
- •History of alcohol or substance abuse (as defined by the Investigator)
- •Female participants who are pregnant or currently breastfeeding
- •Any previous treatment with any interferon product.
- •Vaccinations within 2 weeks or 5 half-lives, whichever is longer, prior to Day 1
- •Blood donation within 30 days prior to Screening
- •Use of any tobacco product more than 5 times within 30 days prior to Screening
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Group 1
Experimental
No dose titration
干预措施: Avonex (Drug)
Group 2
Experimental
Fast dose titration
干预措施: Avonex (Drug)
Group 3
Experimental
Slow dose titration
干预措施: Avonex (Drug)
结局指标
主要结局
To determine whether titration of Avonex reduces the incidence of flu like symptoms
时间窗: 8 weeks
次要结局
- To evaluate the overall safety and tolerability of Avonex IM injections(8 weeks)
研究者
研究点 (1)
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