Healthy Volunteer
Conditions
Brief summary
Following oncolytic virus (OV) administration, the host immune response is initiated immediately and evolves dynamically. However, in clinical OV therapy, it is virtually impossible to capture these immune events in real time. To address this gap, the principal investigator conducted a high-resolution immune monitoring study in a healthy volunteer.
Interventions
BIOLOGICALOTS-412
After hospitalization, OTS-412 was infused for one hour.
Sponsors
Bionoxx Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* A healthy adult
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ANC(absolute neutrophil count) over time | 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16 |
| Changes in lymphocytes count over time | 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLow cytometry | 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16 | CD surface subtyping for each sampling |
Other
| Measure | Time frame |
|---|---|
| Measurement of GFP expressing neutrophils following ex vivo infection with gfp report viral vector combined with CD surface phenotypes. | 4 hour, 48 hour, Day 8, Day 16 |
Countries
South Korea
Outcome results
None listed