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A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07219940•Shine-On Biomedical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Parexel International - Baltimore Early Phase Clinical Unit

Baltimore, Maryland, United States

Key Dates

Start Date

December 1, 2025

Primary Completion Date

December 1, 2026

Completion Date

March 1, 2027

Last Updated

January 26, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy SubjectsExosomeTargeted Therapy

Interventions

SOB100

DRUG

Contacts

Jennifer Ho

CONTACT

+886423272888 rd005@shineon-bio.com

Oscar Yang

CONTACT

rd009@shineon-bio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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