NCT07219940

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shine-On Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-10-22
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study