A Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- EyeGene Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability of EG-COVII in healthy adult volunteers
研究概览
简要总结
This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
详细描述
Subjects will undergo a Screening period beginning up to 2 weeks prior to enrollment, the vaccinations will be administered on week 0 and week 3, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure;
- •Healthy volunteers aged above 18 years at the time of screening;
- •Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster;
- •The last authorised COVID-19 vaccination, the participants received, should be more than 16 weeks prior to the first IP vaccination;
排除标准
- •Participant with the evidence of COVID-19 infection at screening (Positive for COVID-19 with RT-PCR test with nasal mid-turbinate specimen);
- •Participant who has the history of COVID-19 infection within 6 months from the first IP vaccination;
- •Close contact with a person infected with COVID-19 within 2 weeks prior to the first IP vaccination;
研究组 & 干预措施
EG-COVII
干预措施: EG-COVII (Biological)
结局指标
主要结局
Safety and tolerability of EG-COVII in healthy adult volunteers
时间窗: 7 weeks follow up
Number of participants with adverse events (AEs) Number of participants with abnormal clinical laboratory results (hematology /chemistry /urinalysis) Number of participants with abnormal vital sign Number of participants with abnormal physical examination results
次要结局
未报告次要终点