Allergy and ImmunologySAT-008NCT04916145
An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy Adults
A study testing SAT-008 in people with Allergy and Immunology, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy and Immunology
- What is being tested?
- SAT-008
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Oct 2020to 25 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Current infectious disease
- History of autoimmune diseases
- Current immunological compromised diseases.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
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
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.
Read the 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.
- Conditions
- Allergy and Immunology
- Being tested
- SAT-008
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAT-008Device
SAT-008 is a digital device containing several types of activities related to the immune function of adults.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SAT-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 1, Week 5, Week 13
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Measured: Baseline
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Measured: Week 1 (a week following baseline)
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Measured: Week 5 (five weeks following baseline)
Number of expected and unexpected adverse events
To evaluate the safety of SAT-008
Measured: Week 13 (thirteen weeks following baseline)
Rate of adherence to SAT-008
To assess a degree to which participants follow SAT-008
Measured: Week 1 (a week following baseline)
Rate of adherence to SAT-008
To assess a degree to which participants follow SAT-008
Measured: Week 5 (five weeks following baseline)
Rate of adherence to SAT-008
To assess a degree to which participants follow SAT-008
Measured: Week 13 (thirteen weeks following baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start8 Oct 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergy and ImmunologyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital, S-Alpha Therapeutics, Inc.
- Responsible party
- Principal investigator, Yoon-Seok Chang, MD, PhD, Seoul National University Bundang Hospital
- Investigators
- Yoon-Seok Chang, MD, PhD, Principal investigator, addchang@snu.ac.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916145
- Sponsor's protocol ID
- B-2009-637-306
- Acronym
- SAT-008
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37179746
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04916145
- Acronym / sponsor ID
- SAT-008 / B-2009-637-306
- Conditions
- Allergy and Immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital, S-Alpha Therapeutics, Inc.
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: SAT-008Participants randomly assigned to this group will be treated by SAT-008 during the study. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current infectious disease
- History of autoimmune diseases
- Current immunological compromised diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAT-008SAT-008 is a digital device containing several types of activities related to the immune function of adults. | Device | Use of SAT-008 |
Primary outcome
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.
Number of expected and unexpected adverse events
Time frame: Baseline
To evaluate the safety of SAT-008
Number of expected and unexpected adverse events
Time frame: Week 1 (a week following baseline)
To evaluate the safety of SAT-008
Number of expected and unexpected adverse events
Time frame: Week 5 (five weeks following baseline)
To evaluate the safety of SAT-008
Number of expected and unexpected adverse events
Time frame: Week 13 (thirteen weeks following baseline)
To evaluate the safety of SAT-008
Rate of adherence to SAT-008
Time frame: Week 1 (a week following baseline)
To assess a degree to which participants follow SAT-008
Rate of adherence to SAT-008
Time frame: Week 5 (five weeks following baseline)
To assess a degree to which participants follow SAT-008
Rate of adherence to SAT-008
Time frame: Week 13 (thirteen weeks following baseline)
To assess a degree to which participants follow SAT-008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 37179746Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Seok Chang, MD, PhD principal investigator
addchang@snu.ac.kr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAT-008 in people with Allergy and Immunology, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functions of immunocytes (time frame: Baseline, Week 1, Week 5, Week 13). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.