HLA-G-targeted exosome SOB100 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 dose-escalation trial testing SOB100, an exosome decorated with an anti-HLA-G nanobody, in healthy adult volunteers. Participants will receive escalating doses of SOB100 to measure tolerability, safety, and pharmacokinetics with close monitoring including physical exams, ECGs, and laboratory tests. Eligible volunteers are adults with no active infections, no history of cancer, adequate organ function, and appropriate contraception when required. Safety findings and PK data will guide dose-escalation decisions and inform future patient studies.

Why it matters

Who can join: the full rules

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

Where it's running

• Parexel International - Baltimore Early Phase Clinical Unit
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Jennifer Ho
• Email: rd005@shineon-bio.com
• Phone: +886423272888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.