An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Allergy and Immunology

Intervention / Treatment
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* Device: SAT-008


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two study arms. One group (treatment) will receive an experimental digital device for 13 weeks while the other group (control) will maintain daily activity as usual.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No any treatment<br>Participants randomly assigned to this group will maintain a routine life without any treatments (no use of SAT-008). | |
| Experimental: Use of SAT-008<br>Participants randomly assigned to this group will be treated by SAT-008 during the study. | Device: SAT-008<br>* SAT-008 is a digital device containing several types of activities related to the immune function of adults.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functions of immunocytes | To measure changes in functions of natural killer cells, T cells, and B cells at 1, 5, and 13 weeks compared to baseline. | Baseline, Week 1, Week 5, Week 13 | 
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Baseline | 
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Week 1 (a week following baseline) | 
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Week 5 (five weeks following baseline) | 
| Number of expected and unexpected adverse events | To evaluate the safety of SAT-008 | Week 13 (thirteen weeks following baseline) | 
| Rate of adherence to SAT-008 | To assess a degree to which participants follow SAT-008 | Week 1 (a week following baseline) | 
| Rate of adherence to SAT-008 | To assess a degree to which participants follow SAT-008 | Week 5 (five weeks following baseline) | 
| Rate of adherence to SAT-008 | To assess a degree to which participants follow SAT-008 | Week 13 (thirteen weeks following baseline) |