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

NCT04916145 | Completed

• 1 other identifier: B-2009-637-306
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy and Immunology

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

No any treatment

NO INTERVENTION

Participants randomly assigned to this group will maintain a routine life without any treatments (no use of SAT-008).

Use of SAT-008

EXPERIMENTAL

Participants randomly assigned to this group will be treated by SAT-008 during the study.

Device: SAT-008

Interventions

SAT-008 DEVICE

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

Use of SAT-008

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current infectious disease
• History of autoimmune diseases
• Current immunological compromised diseases.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Korea University Guro Hospital: collaborator
• S-Alpha Therapeutics, Inc.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (1)

• Choi JP, Ayoub G, Ham J, Huh Y, Choi SE, Hwang YK, Noh JY, Kim SH, Song JY, Kim ES, Chang YS. Exercise With a Novel Digital Device Increased Serum Anti-influenza Antibody Titers After Influenza Vaccination. Immune Netw. 2023 Feb 27;23(2):e18. doi: 10.4110/in.2023.23.e18. eCollection 2023 Apr.

  PMID: 37179746 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Yoon-Seok Chang, MD, PhD

  addchang@snu.ac.kr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 7, 2021
• Study Start: October 8, 2020
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

KR (1)