Who is eligible for clinical trial NCT07219940?

Participants must meet protocol criteria for Healthy Subjects. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07219940 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-01-22

A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects (NCT07219940)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Shine-On Biomedical Co., Ltd.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).

Location: Parexel International - Baltimore Early Phase Clinical Unit — Baltimore, Maryland

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Parexel International - Baltimore Early Phase Clinical Unit — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗