A Single-volunteer Study of Immune Response Following OTS-412 Vaccinia Virus Systemic Injection(Self-experiment)

Early Phase 1CompletedNCT07302945

Bionoxx Inc.1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

OTS-412BIOLOGICAL

After hospitalization, OTS-412 was infused for one hour.

Eligibility

Sex: MALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A healthy adult Exclusion Criteria: * N/A

Locations (1)

Pusan National University Medical college

Busan, South Korea

Outcomes

Primary Outcomes

Changes in ANC(absolute neutrophil count) over time

Time frame: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Changes in lymphocytes count over time

Time frame: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Secondary Outcomes

FLow cytometry

CD surface subtyping for each sampling

Time frame: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Data from ClinicalTrials.gov

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