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

NCT07219940 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SOB100-CL-Proto-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse event (AE)

  From start until 3 weeks after the last dose of SOB100

• Incidence of serious adverse event (SAE)

  From start until 3 weeks after the last dose of SOB100

• Incidence of treatment-emergent adverse event (TEAE)

  From start until 3 weeks after the last dose of SOB100

• Abnormalities in physical examination (PE)

  From start until 3 weeks after the last dose of SOB100

• Abnormalities in ECG

  From start until 3 weeks after the last dose of SOB100

Other Outcomes (3)

• Area Under the Curve of SOB100 (AUC)

  From baseline to 3 weeks after the last dose of SOB100

• Maximum observed plasma concentration of SOB100 (Cmax)

  From baseline to 3 weeks after the last dose of SOB100

• Half-life of SOB100 (T1/2)

  From baseline to 3 weeks after the last dose of SOB100

Study Arms (1)

SOB100

EXPERIMENTAL

Drug: SOB100

Interventions

SOB100 DRUG

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

SOB100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shine-On Biomedical Co., Ltd.: lead

Study Sites (1)

Parexel International - Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

RECRUITING

Central Study Contacts

Jennifer Ho

CONTACT

+886423272888; rd005@shineon-bio.com

Oscar Yang

CONTACT

rd009@shineon-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2025
• First Posted: October 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)