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Completed

NCT Number: NCT04916145

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

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.

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Key information

Conditions

Allergy and Immunology Hypersensitivity Immune System Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAT-008

Device

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

Primary outcomes

  1. 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.

  2. Number of expected and unexpected adverse events

    Time frame: Baseline

    To evaluate the safety of SAT-008

  3. Number of expected and unexpected adverse events

    Time frame: Week 1 (a week following baseline)

    To evaluate the safety of SAT-008

  4. Number of expected and unexpected adverse events

    Time frame: Week 5 (five weeks following baseline)

    To evaluate the safety of SAT-008

  5. Number of expected and unexpected adverse events

    Time frame: Week 13 (thirteen weeks following baseline)

    To evaluate the safety of SAT-008

  6. Rate of adherence to SAT-008

    Time frame: Week 1 (a week following baseline)

    To assess a degree to which participants follow SAT-008

  7. Rate of adherence to SAT-008

    Time frame: Week 5 (five weeks following baseline)

    To assess a degree to which participants follow SAT-008

  8. Rate of adherence to SAT-008

    Time frame: Week 13 (thirteen weeks following baseline)

    To assess a degree to which participants follow SAT-008

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Korea University Guro Hospital
  • S-Alpha Therapeutics, Inc.

Registry information

Official study title

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

Acronym: SAT-008

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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