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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOB100 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOB100 | Drug | Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event (AE) | From start until 3 weeks after the last dose of SOB100 | |
| Incidence of serious adverse event (SAE) | From start until 3 weeks after the last dose of SOB100 | |
| Incidence of treatment-emergent adverse event (TEAE) | From start until 3 weeks after the last dose of SOB100 | |
| Abnormalities in physical examination (PE) | From start until 3 weeks after the last dose of SOB100 | |
| Abnormalities in ECG | From start until 3 weeks after the last dose of SOB100 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of SOB100 (AUC) | Pharmacokinetics (PK) parameters | From baseline to 3 weeks after the last dose of SOB100 |
| Maximum observed plasma concentration of SOB100 (Cmax) | Pharmacokinetics (PK) parameters |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ho | Contact | +886423272888 | rd005@shineon-bio.com | |
| Oscar Yang | Contact | rd009@shineon-bio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International - Baltimore Early Phase Clinical Unit | Recruiting | Baltimore | Maryland | 21225 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42083744 | Derived | 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. |
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| From baseline to 3 weeks after the last dose of SOB100 |
| Half-life of SOB100 (T1/2) | Pharmacokinetics (PK) parameters | From baseline to 3 weeks after the last dose of SOB100 |