Actively Recruiting
A Study to Investigate 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
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigational drug, SOB100, is an HLA-G targeted exosome equipped with a nanobody namely anti-HLA-G VHH on the exosome membrane. This is a Phase I dose escalation study to exam the tolerability, safety, and pharmacokinetics in healthy subjects.
CONDITIONS
Official Title
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged ≥ 18 years old
- Overtly healthy subject, who is considered to be generally healthy based on medical history, 12-lead ECG, and physical examinations, as judged by the Investigator
- Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)
- Adequate organ function
You will not qualify if you...
- With known or suspected to be hypersensitivity to HLA-G related treatment.
- Confirmed active HIV, HBV, or HCV infection
- With active fungal, bacterial, viral or atypical infection requiring systemic medication
- History of cancer (malignancy) or have ever received any anti-cancer therapy
- Has ever received cell therapy or organ transplantation
- Substance abuse or addictive use of drugs for nonmedical purposes
- Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception
- Male subjects with a female spouse/partner who is of childbearing potential refuse to adopt at least one highly effective method of contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Parexel International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Actively Recruiting
Research Team
J
Jennifer Ho
CONTACT
O
Oscar Yang
CONTACT
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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