A study to investigate HLA-G targeted exosome (SOB100) in healthy subjects.
Kai-Jie Yang, Ni-Yen Yu, Ronald Goldwater...
https://pubmed.ncbi.nlm.nih.gov/42083744Actively Recruiting
Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID07219940
An Open-label and Dose-escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of HLA-G-targeted Exosome SOB100 in Healthy Subjects
Led by Shine-On Biomedical Co., Ltd. · Updated on 2026-01-26
15
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 65 18 years old
- Generally healthy based on medical history, ECG, and physical exams as judged by the investigator
- Able to understand the study and comply with procedures, and sign informed consent
- Adequate organ function
You will not qualify if you...
- Known or suspected hypersensitivity to HLA-G related treatment
- Active HIV, HBV, or HCV infection
- Active fungal, bacterial, viral, or atypical infection requiring systemic medication
- History of cancer or prior anti-cancer therapy
- Previous cell therapy or organ transplantation
- Substance abuse or addictive drug use for nonmedical reasons
- Female lactating, pregnant, or unwilling to use highly effective contraception
- Male with female partner of childbearing potential unwilling to use highly effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until the last dose is administered
Participants receive SOB100 during the dose escalation phase to evaluate its safety and tolerability.
Visit schedule depends on dose escalation protocol
Follow-up
Duration - 3 weeks
Participants are monitored for safety and adverse events for 3 weeks after the last dose of SOB100.
Approximately weekly visits for safety assessments
Trial Site Locations
Total: 1 location
1
Parexel International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Actively Recruiting
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Research Team
J
Jennifer Ho
O
Oscar Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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