HLA-G-targeted exosome SOB100 in healthy adults

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

This trial will test whether a new HLA-G-targeted exosome called SOB100 is safe and how it behaves in the body when given to healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shine-On Biomedical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07219940 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older who are overtly healthy with adequate organ function, no active infections or cancer history, and able to comply with study procedures and contraception requirements.

Not a fit: People with active HIV, HBV, or HCV infection, ongoing systemic infections, prior cancer or organ/cell transplantation, known hypersensitivity to HLA-G related treatments, pregnant or lactating individuals, or those with substance abuse are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, SOB100 could establish a safe HLA-G-targeted exosome platform that enables development of therapies that modulate immune responses.

How similar studies have performed: Exosome-based therapeutics have shown preclinical promise, but HLA-G-targeted exosomes are a novel approach and have limited to no prior human data.

Eligibility criteria

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 this trial is running

Baltimore, Maryland

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

Study contacts

• Study coordinator: Jennifer Ho

Conditions Healthy Subjects; Exosome; Targeted Therapy