Recruiting
Phase 1

SOB100

Sponsor:

Shine-On Biomedical Co., Ltd.

Code:

NCT07219940

Conditions

Healthy Subjects

Exosome

Targeted Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SOB100

Study Details

Brief 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.

Conditions

Healthy Subjects

Exosome

Targeted Therapy

Study ID

NCT07219940

Start date

Dec 1, 2025

Status verified date

Oct, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SOB100

Interventions

SOB100

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Parexel International - Baltimore Early Phase Clinical Unit

Recruiting

Baltimore, Maryland, United States, 21225

Contacts

Dr. Ronald Goldwater, MDCM, M.Sc(A), CPI

877-617-8839study.baltimore@parexel.com

More Information

Sponsor

Shine-On Biomedical Co., Ltd.

Last update posted

Jan 26, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shine-On Biomedical Co., Ltd. on 2026-01-26.