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
Shine-On Biomedical Co., Ltd.
15 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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, safety, and pharmacokinetics in healthy subjects.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07219940