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RecruitingNCT07219940αHLA-G Exo-01Updated Jan 26, 2026

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

A Phase 1 interventional study of SOB100 in Healthy Subjects, Exosome and Targeted Therapy, sponsored by Shine-On Biomedical Co., Ltd.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Shine-On Biomedical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Healthy Subjects
  • Exosome
  • Targeted Therapy
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In context

Lead sponsor

Shine-On Biomedical Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    SOB100

    Drug: SOB100

Interventions

  • DrugSOB100

    Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.

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What researchers measure

Primary outcomes

  1. Incidence of adverse event (AE)

    Time frame: From start until 3 weeks after the last dose of SOB100

  2. Incidence of serious adverse event (SAE)

    Time frame: From start until 3 weeks after the last dose of SOB100

  3. Incidence of treatment-emergent adverse event (TEAE)

    Time frame: From start until 3 weeks after the last dose of SOB100

  4. Abnormalities in physical examination (PE)

    Time frame: From start until 3 weeks after the last dose of SOB100

  5. Abnormalities in ECG

    Time frame: From start until 3 weeks after the last dose of SOB100

Other outcomes

  1. Area Under the Curve of SOB100 (AUC)

    Pharmacokinetics (PK) parameters

    Time frame: From baseline to 3 weeks after the last dose of SOB100

  2. Maximum observed plasma concentration of SOB100 (Cmax)

    Pharmacokinetics (PK) parameters

    Time frame: From baseline to 3 weeks after the last dose of SOB100

  3. Half-life of SOB100 (T1/2)

    Pharmacokinetics (PK) parameters

    Time frame: From baseline to 3 weeks after the last dose of SOB100

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Study locations

1 of 1 sites recruiting
  • Parexel International - Baltimore Early Phase Clinical Unit
    Baltimore, Maryland 21225, United States
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07219940
Lead sponsor
Shine-On Biomedical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 22, 2025
Start date
Dec 1, 2025
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jan 26, 2026

Study contacts

Jennifer Ho
Contact
rd005@shineon-bio.com
+886423272888
Oscar Yang
Contact
rd009@shineon-bio.com

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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