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

Seoul National University

Status: Completed

Conditions: Allergy and Immunology

Treatments: Device: SAT-008

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04916145

B-2009-637-306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

No any treatment

No Intervention group

Description:

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

Use of SAT-008

Experimental group

Description:

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

Treatment:

Device: SAT-008