A Single-center, Randomized, Open Label, No-treatment Controlled, Digital Device Study to Evaluate the Efficacy, Safety and Feasibility of SAT-008 in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes in functions of immunocytes
研究概览
简要总结
The purpose of this exploratory study is to evaluate the efficacy, safety, and feasibility of a novel digital device called SAT-008 in healthy adults.
详细描述
This clinical study was designed as a single institution, open, controlled, and investigator-led clinical trial to evaluate the efficacy, safety, and feasibility of a novel digital device called SAT-008 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 50 years
- •Received influenza vaccination the previous year
- •Scheduled to receive the influenza vaccine
- •Voluntarily agrees with a consent form
排除标准
- •Current infectious disease
- •History of autoimmune diseases
- •Current immunological compromised diseases.
结局指标
主要结局
Changes in functions of immunocytes
时间窗: Baseline, Week 1, Week 5, Week 13
To measure changes in functions of natural killer cells, T cells, and B cells at 1, 5, and 13 weeks compared to baseline.
Number of expected and unexpected adverse events
时间窗: Week 13 (thirteen weeks following baseline)
To evaluate the safety of SAT-008
Rate of adherence to SAT-008
时间窗: Week 13 (thirteen weeks following baseline)
To assess a degree to which participants follow SAT-008
次要结局
未报告次要终点
研究者
Yoon-Seok Chang, MD, PhD
Professor
Seoul National University Bundang Hospital