NCT01015703已完成1 期
A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety Events
研究概览
简要总结
The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI)
- •Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG.
- •Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission.
排除标准
- •History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption.
- •Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing
- •Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis
结局指标
主要结局
Safety Events
时间窗: Duration of study
Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.
次要结局
未报告次要终点
研究者
研究点 (2)
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