NCT07219940 · Shine-On Biomedical Co., Ltd.
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
(αHLA-G Exo-01)
What this study is about
The experimental 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 gradually increasing doses study to exam the tolerability, safety, and how the drug moves through the body in healthy subjects.
View original scientific description
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.
Interventions
DRUG
SOB100
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Primary outcome measures
Incidence of adverse event (AE)
Time frame: From start until 3 weeks after the last dose of SOB100
Incidence of serious adverse event (SAE)
Time frame: From start until 3 weeks after the last dose of SOB100
Incidence of treatment-emergent adverse event (TEAE)
Time frame: From start until 3 weeks after the last dose of SOB100
Abnormalities in physical examination (PE)
Time frame: From start until 3 weeks after the last dose of SOB100
Abnormalities in ECG
Time frame: From start until 3 weeks after the last dose of SOB100
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations