A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SOB100.
- Who it may be relevant to
- Registry conditions: Healthy Subjects, Exosome, Targeted Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug SOB100
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Primary outcome measures
- Incidence of adverse event (AE) [Time frame: From start until 3 weeks after the last dose of SOB100]
- Incidence of serious adverse event (SAE) [Time frame: From start until 3 weeks after the last dose of SOB100]
- Incidence of treatment-emergent adverse event (TEAE) [Time frame: From start until 3 weeks after the last dose of SOB100]
- Abnormalities in physical examination (PE) [Time frame: From start until 3 weeks after the last dose of SOB100]
- Abnormalities in ECG [Time frame: From start until 3 weeks after the last dose of SOB100]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Parexel International - Baltimore Early Phase Clinical Unit — Baltimore
Publications
- Yang KJ, Yu NY, Goldwater R, Chang CH, Liu CM, Kan KW, Chen YW, Cho DY, Melville D, Ho JH. A study to investigate HLA-G targeted exosome (SOB100) in healthy subjects. Nanomedicine (Lond). 2026 Jun;21(11):1565-1569. doi: 10.1080/17435889.2026.2668706. Epub 2026 May 5. PMID 42083744
Identifiers
NCT: NCT07219940 · SOB100-CL-Proto-01