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A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
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
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: 1. Male or female subjects aged ≥ 18 years old 2. 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 3. Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF) 4. Adequate organ function Exclusion Criteria: 1. With known or suspected to be hypersensitivity to HLA-G related treatment. 2. Confirmed active HIV, HBV, or HCV infection 3. With active fungal, bacterial, viral or atypical infection requiring systemic medication 4. History of cancer (malignancy) or have ever received any anti-cancer therapy 5. Has ever received cell therapy or organ transplantation 6. Substance abuse or addictive use of drugs for nonmedical purposes 7. Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception 8. Male subjects with a female spouse/partner who is of childbearing potential refuse to adopt at least one highly effective method of contraception
About the study
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.
What is being tested
- SOB100 (drug)
Sponsor: Shine-On Biomedical Co., Ltd. · Participants: 15 · Started: Dec 1, 2025
Contact the study team
- Jennifer Ho · Phone: +886423272888
Official record on ClinicalTrials.gov — NCT07219940
Locations in the U.S.
| Maryland | Parexel International - Baltimore Early Phase Clinical Unit, Baltimore |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.