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

RecruitingPhase 1Healthy volunteers welcome

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

Sponsor: Shine-On Biomedical Co., Ltd. · Participants: 15 · Started: Dec 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07219940

Locations in the U.S.

MarylandParexel 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.