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

December 23, 2025 updated by: Bionoxx Inc.

High-Resolution Immune Dynamics Following OTS-412 Oncolytic Vaccinia Virus Administration in a Healthy Volunteer(Self-experiment)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea, 50612
        • Pusan National University Medical college

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • A healthy adult

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OV Treated healthy arm
Biological: OTS-412
After hospitalization, OTS-412 was infused for one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLow cytometry
Time Frame: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16
CD surface subtyping for each sampling
4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Other Outcome Measures

Outcome Measure
Time Frame
Measurement of GFP expressing neutrophils following ex vivo infection with gfp report viral vector combined with CD surface phenotypes.
Time Frame: 4 hour, 48 hour, Day 8, Day 16
4 hour, 48 hour, Day 8, Day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionoxx Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

May 2, 2022

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • OTS412-HV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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