jRCT2031250033招募中不适用
A Phase I study evaluating safety, tolerability, and immunogenicity of FPP004X intramuscularly administered (FPP004X-JP-SAR-01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 50age old not（—）
- 性别
- Male
入选标准
- •Healthy adults(Part 1):
- •Males aged >= 18 to < 45 years at the time of consent
- •Body mass index (BMI) >= 18.5 kg/m2 to < 25.0 kg/m2
- •Patients with seasonal allergic rhinitis(Part 2):
- •Males aged >= 18 to < 50 years at the time of consent
- •Body mass index (BMI) >= 17.6 kg/m2 to < 26.5 kg/m2
排除标准
- •Subjects who who have participated (been vaccinated) in a clinical trial of an unapproved vaccine within 1 year prior to the start of the clinical trial (starting from the date of administration of the investigational drug)
- •Subjects who have been diagnosed with immunodeficiency or autoimmune disease
- •Subjects who have or have a history of allergic diseases (atopic dermatitis, bronchial asthma, etc.)
- •Subjects who have a history of hypersensitivity to any component of the investigational product
- •Subjects who are judged by the investigator (subinvestigator) to be ineligible for this clinical trial
结局指标
主要结局
-
Safety, tolerability and immunogenicity
次要结局
未报告次要终点
研究者
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