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OpenTrials
Completed

NCT Number: NCT07302945

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

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Key information

Conditions

Healthy Volunteer

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Pusan National University Medical college

Busan, 50612, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A healthy adult

Exclusion criteria

  • N/A

Treatment and study plan

OTS-412

Biological

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

Primary outcomes

  1. 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

  2. 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

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bionoxx Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 24, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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