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

Recruiting now · Phase 1

Conditions studied: Healthy Subjects, Exosome, Targeted Therapy

In brief

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.

Key facts

Study ID

NCT07219940

Run by

Shine-On Biomedical Co., Ltd.

People needed

15

Starts

2025-12-01

Expected to finish

2027-03-01

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Parexel International - Baltimore Early Phase Clinical Unit — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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