Exosome, Healthy Subjects, Targeted Therapy
Conditions
Brief summary
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
DRUGSOB100
Drug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Sponsors
Shine-On Biomedical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects aged ≥ 18 years old 2. 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 3. Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF) 4. Adequate organ function
Exclusion criteria
1. With known or suspected to be hypersensitivity to HLA-G related treatment. 2. Confirmed active HIV, HBV, or HCV infection 3. With active fungal, bacterial, viral or atypical infection requiring systemic medication 4. History of cancer (malignancy) or have ever received any anti-cancer therapy 5. Has ever received cell therapy or organ transplantation 6. Substance abuse or addictive use of drugs for nonmedical purposes 7. Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception 8. Male subjects with a female spouse/partner who is of childbearing potential refuse to adopt at least one highly effective method of contraception
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
CONTACTJennifer Ho
CONTACTOscar Yang
Outcome results
None listed