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

June 3, 2021 updated by: Yoon-Seok Chang, MD, PhD, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 1, Week 5, Week 13
Number of expected and unexpected adverse events
Time Frame: Baseline
To evaluate the safety of SAT-008
Baseline
Number of expected and unexpected adverse events
Time Frame: Week 1 (a week following baseline)
To evaluate the safety of SAT-008
Week 1 (a week following baseline)
Number of expected and unexpected adverse events
Time Frame: Week 5 (five weeks following baseline)
To evaluate the safety of SAT-008
Week 5 (five weeks following baseline)
Number of expected and unexpected adverse events
Time Frame: Week 13 (thirteen weeks following baseline)
To evaluate the safety of SAT-008
Week 13 (thirteen weeks following baseline)
Rate of adherence to SAT-008
Time Frame: Week 1 (a week following baseline)
To assess a degree to which participants follow SAT-008
Week 1 (a week following baseline)
Rate of adherence to SAT-008
Time Frame: Week 5 (five weeks following baseline)
To assess a degree to which participants follow SAT-008
Week 5 (five weeks following baseline)
Rate of adherence to SAT-008
Time Frame: Week 13 (thirteen weeks following baseline)
To assess a degree to which participants follow SAT-008
Week 13 (thirteen weeks following baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Korea University Guro Hospital
S-Alpha Therapeutics, Inc.

Investigators

  • Principal Investigator: Yoon-Seok Chang, MD, PhD, addchang@snu.ac.kr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Actual)

January 25, 2021

Study Completion (Actual)

January 25, 2021

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • B-2009-637-306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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