An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy Adults
Not Applicable
Completed
- Conditions
- Allergy and Immunology
- Interventions
- Device: SAT-008
- Registration Number
- NCT04916145
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- 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
Exclusion Criteria
- Current infectious disease
- History of autoimmune diseases
- Current immunological compromised diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Use of SAT-008 SAT-008 Participants randomly assigned to this group will be treated by SAT-008 during the study.
- Primary Outcome Measures
Name Time Method Changes in functions of immunocytes 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 Week 13 (thirteen weeks following baseline) To evaluate the safety of SAT-008
Rate of adherence to SAT-008 Week 13 (thirteen weeks following baseline) To assess a degree to which participants follow SAT-008
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of