Healthy SubjectsPhase 1αHLA-G Exo-01NCT07219940
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
A Phase 1 study testing SOB100 in people with Healthy Subjects and Exosome, run by Shine-On Biomedical Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Exosome, Targeted Therapy
- What is being tested?
- SOB100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oscar Yang contact
United States1 site, 1 recruiting
- Recruiting
Parexel International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225
Dr. Ronald Goldwater, MDCM, M.Sc(A), CPI, 877-617-8839, study.baltimore@parexel.com
About this study
Official title: 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
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.
- Conditions
- Healthy Subjects, Exosome, Targeted Therapy
- Being tested
- SOB100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOB100Drug
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
| Study group | Role | What they receive |
|---|---|---|
| SOB100 | Experimental | Not described Receives: Drug: SOB100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE)
Measured: From start until 3 weeks after the last dose of SOB100
Incidence of serious adverse event (SAE)
Measured: From start until 3 weeks after the last dose of SOB100
Incidence of treatment-emergent adverse event (TEAE)
Measured: From start until 3 weeks after the last dose of SOB100
Abnormalities in physical examination (PE)
Measured: From start until 3 weeks after the last dose of SOB100
Abnormalities in ECG
Measured: From start until 3 weeks after the last dose of SOB100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shine-On Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219940
- Sponsor's protocol ID
- SOB100-CL-Proto-01
- Acronym
- αHLA-G Exo-01
- Status last verified
- Oct 2025
- First submitted
- 19 Oct 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang KJ, Yu NY, Goldwater R, Chang CH, Liu CM, Kan KW, Chen YW, Cho DY, Melville D, Ho JH. A study to investigate HLA-G targeted exosome (SOB100) in healthy subjects. Nanomedicine (Lond). 2026 Jun;21(11):1565-1569. doi: 10.1080/17435889.2026.2668706. Epub 2026 May 5.
PubMed 42083744
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07219940
- Acronym / sponsor ID
- αHLA-G Exo-01 / SOB100-CL-Proto-01
- Conditions
- Healthy Subjects, Exosome, Targeted Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shine-On Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOB100 | Experimental | Drug: SOB100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOB100Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase. | Drug | SOB100 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 42083744Yang KJ, Yu NY, Goldwater R, Chang CH, Liu CM, Kan KW, Chen YW, Cho DY, Melville D, Ho JH. A study to investigate HLA-G targeted exosome (SOB100) in healthy subjects. Nanomedicine (Lond). 2026 Jun;21(11):1565-1569. doi: 10.1080/17435889.2026.2668706. Epub 2026 May 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar Yang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOB100 in people with Healthy Subjects and Exosome, run by Shine-On Biomedical Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ho (+886423272888, rd005@shineon-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event (AE) (time frame: From start until 3 weeks after the last dose of SOB100). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07219940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.