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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Shine-On Biomedical Co., Ltd.
Study ID
NCT07219940
Phase
PHASE1
Status
Recruiting
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Conditions

  • Exosome
  • Healthy Subjects
  • Targeted Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SOB100

Primary Outcome Measure

Incidence of adverse event (AE) [ Time Frame: From start until 3 weeks after the last dose of SOB100 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Parexel International - Baltimore Early Phase Clinical UnitBaltimoreMaryland21225
Dr. Ronald Goldwater, MDCM, M.Sc(A), CPI
[email protected]
877-617-8839

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By research site
Parexel International - Baltimore Early Phase Clinical Unit· Baltimore, MD

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