Phase I Study to Evaluate Safety and Dosage of SOB100, an HLA-G Targeted Exosome, in Healthy Adults

What this Trial Is About

This research aims to evaluate the investigational drug SOB100, which is a special exosome designed to target HLA-G. This Phase I clinical trial focuses on studying the safety, tolerability, and how the body processes SOB100 in healthy adult volunteers. The study is conducted by Shine-On Biomedical Co., Ltd. and involves healthy subjects without known medical conditions affecting the study. Participants will receive SOB100 during a dose escalation phase, where increasing doses are given to assess safety and tolerability. This is an open-label study, meaning that both researchers and participants know they are receiving SOB100, without placebo or blinding. The study timeline spans from the initial dosing through three weeks after the last dose. During the study, participants will undergo physical examinations, ECG monitoring, and regular safety assessments to detect any adverse events or abnormalities. Researchers will carefully track any side effects, serious adverse events, and treatment-emergent events throughout the study and for three weeks after dosing finishes. The total participation length covers dosing and follow-up to ensure a thorough safety evaluation.

A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects