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NCT Number: NCT07219940

A Study to Investigate 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.

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Key information

Conditions

Healthy Subjects Exosome Targeted Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International - Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

877-617-8839

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOB100

Drug

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

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)

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

    Pharmacokinetics (PK) parameters

  2. Maximum observed plasma concentration of SOB100 (Cmax)

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

    Pharmacokinetics (PK) parameters

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

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

    Pharmacokinetics (PK) parameters

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Ho

CONTACT

[email protected]

+886423272888

Oscar Yang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shine-On Biomedical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: αHLA-G Exo-01

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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