[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609850":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":28,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Shine-On Biomedical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SOB100","EXPERIMENTAL",null,[13],"Drug: SOB100",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Jennifer Ho","CONTACT","+886423272888","rd005@shineon-bio.com",{"name":26,"role":22,"phone":11,"phoneExt":11,"email":27},"Oscar Yang","rd009@shineon-bio.com",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Parexel International - Baltimore Early Phase Clinical Unit","RECRUITING","Baltimore","Maryland","21225","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-76.61219,39.29038,{"lat":41,"lon":40},[44],{"name":45,"role":22,"phone":46,"phoneExt":11,"email":47},"Dr. Ronald Goldwater, MDCM, M.Sc(A), CPI","877-617-8839","study.baltimore@parexel.com",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609850","phase-1-a-study-to-investigate-hla-g-targeted-exosome-sob100-in-healthy-subjects-100609850",false,"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","αHLA-G Exo-01","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old\n2. 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\n3. Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)\n4. Adequate organ function\n\nExclusion Criteria:\n\n1. With known or suspected to be hypersensitivity to HLA-G related treatment.\n2. Confirmed active HIV, HBV, or HCV infection\n3. With active fungal, bacterial, viral or atypical infection requiring systemic medication\n4. History of cancer (malignancy) or have ever received any anti-cancer therapy\n5. Has ever received cell therapy or organ transplantation\n6. Substance abuse or addictive use of drugs for nonmedical purposes\n7. Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception\n8. Male subjects with a female spouse\u002Fpartner who is of childbearing potential refuse to adopt at least one highly effective method of contraception",true,"ALL","18 Years",{"count":62,"type":63},15,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","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.",[69,70,71],"Healthy Subjects","Exosome","Targeted Therapy","2026-01-22",{"date":74,"type":75},"2026-01-26","ACTUAL",{"date":77,"type":75},"2025-12-01",{"date":79,"type":63},"2027-03",{"name":5,"class":6},1]