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

NCT ID: NCT07302945

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2022-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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OV Treated healthy arm

Group Type EXPERIMENTAL

OTS-412

Intervention Type BIOLOGICAL

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

Interventions

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OTS-412

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A healthy adult

Exclusion Criteria

* N/A
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bionoxx Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pusan National University Medical college

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OTS412-HV

Identifier Type: -

Identifier Source: org_study_id