Healthy SubjectsHealthy volunteersDrugPhase 1
What this study is
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.
What's being tested
- SOB100
Intervention · DRUG
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Study details
- Official 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
- Sponsor
- Shine-On Biomedical Co., Ltd.
- Conditions
- Healthy Subjects · Exosome · Targeted Therapy
- Enrolling
- 15 people
- Starts
- 2025-12-01
- Est. completion
- 2027-03
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openParexel International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States
- Dr. Ronald Goldwater, MDCM, M.Sc(A), CPI · Contact877-617-8839study.baltimore@parexel.com
Recruiting
Study team
Sponsor
Shine-On Biomedical Co., Ltd.
Study ID SOB100-CL-Proto-01
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.