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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allergy and Immunology
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Changes in functions of immunocytes
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Yoon-Seok Chang, MD, PhD
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes in functions of immunocytes
Time Frame: 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
Time Frame: Week 13 (thirteen weeks following baseline)
To evaluate the safety of SAT-008
Rate of adherence to SAT-008
Time Frame: Week 13 (thirteen weeks following baseline)
To assess a degree to which participants follow SAT-008