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RecruitingAccepts healthy volunteersPhase 1

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

Shine-On Biomedical Co., Ltd. · NCT07219940

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
15
US sites recruiting
1
Study start
December 1, 2025
Record last updated
January 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SOB100

Conditions: Healthy Subjects; Exosome; Targeted Therapy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 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

Recruiting US locations

  • Parexel International - Baltimore Early Phase Clinical Unit

    Baltimore, MD 21225

    Site contact: Dr. Ronald Goldwater, MDCM, M.Sc(A), CPI · 877-617-8839 · study.baltimore@parexel.com

Study contacts (from the official record)

  • Jennifer Ho · +886423272888 · rd005@shineon-bio.com
  • Oscar Yang · rd009@shineon-bio.com
All healthy volunteers studies in Maryland →
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy… (NCT07219940) | Bored Studies