A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShine-On Biomedical Co., Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SOB100
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov