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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SOB100
DrugDrug: SOB100 Participants will receive SOB100 and evaluate the safety and tolerability of SOB100 during the dose escalation phase.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: SOB100Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse event (AE)
Time frame
From start until 3 weeks after the last dose of SOB1002
Incidence of serious adverse event (SAE)
Time frame
From start until 3 weeks after the last dose of SOB1003
Incidence of treatment-emergent adverse event (TEAE)
Time frame
From start until 3 weeks after the last dose of SOB1004
Abnormalities in physical examination (PE)
Time frame
From start until 3 weeks after the last dose of SOB100Other outcomes
1
Area Under the Curve of SOB100 (AUC)
Pharmacokinetics (PK) parameters
Time frame
From baseline to 3 weeks after the last dose of SOB1002
Maximum observed plasma concentration of SOB100 (Cmax)
Pharmacokinetics (PK) parameters
Time frame
From baseline to 3 weeks after the last dose of SOB1003
Half-life of SOB100 (T1/2)
Pharmacokinetics (PK) parameters
Time frame
From baseline to 3 weeks after the last dose of SOB100Sponsors and contacts
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Source ClinicalTrials.gov