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
Shine-On Biomedical Co., Ltd.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 infectio…
Interventions
- DrugSOB100
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Location
- Parexel International - Baltimore Early Phase Clinical UnitBaltimore, Maryland