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

Allergy and Immunology Clinical Trial

— SAT-008  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916145
• Other study ID #: B-2009-637-306
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: June 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy and Immunology

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Korea University Guro Hospital, S-Alpha Therapeutics, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of expected and unexpected adverse events	To evaluate the safety of SAT-008	Baseline
Primary	Number of expected and unexpected adverse events	To evaluate the safety of SAT-008	Week 1 (a week following baseline)
Primary	Number of expected and unexpected adverse events	To evaluate the safety of SAT-008	Week 5 (five weeks following baseline)
Primary	Number of expected and unexpected adverse events	To evaluate the safety of SAT-008	Week 13 (thirteen weeks following baseline)
Primary	Rate of adherence to SAT-008	To assess a degree to which participants follow SAT-008	Week 1 (a week following baseline)
Primary	Rate of adherence to SAT-008	To assess a degree to which participants follow SAT-008	Week 5 (five weeks following baseline)
Primary	Rate of adherence to SAT-008	To assess a degree to which participants follow SAT-008	Week 13 (thirteen weeks following baseline)