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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04916145

Acronym

SAT-008

Enrollment

Registered

2021-06-07

Start date

2020-10-08

Completion date

2021-01-25

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy and Immunology

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.

Interventions

DEVICESAT-008

SAT-008 is a digital device containing several types of activities related to the immune function of adults.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline	To evaluate the safety of SAT-008
Rate of adherence to SAT-008	Week 1 (a week following baseline)	To assess a degree to which participants follow SAT-008

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026