Status:
NOT_YET_RECRUITING
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
Lead Sponsor:
Shine-On Biomedical Co., Ltd.
Conditions:
Healthy Subjects
Exosome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07219940
Start Date
November 1 2025
End Date
March 1 2027
Last Update
November 5 2025
Active Locations (1)
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1
Parexel International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225