Healthy VolunteerEarly Phase 1NCT07302945
A Single-volunteer Study of Immune Response Following OTS-412 Vaccinia Virus Systemic Injection(Self-experiment)
A Early Phase 1 study testing OTS-412 in people with Healthy Volunteer, run by Bionoxx Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- OTS-412
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2022to 2 May 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A healthy adult
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteer
- Being tested
- OTS-412
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTS-412Biological
After hospitalization, OTS-412 was infused for one hour.
| Study group | Role | What they receive |
|---|---|---|
| OV Treated healthy arm | Experimental | Not described Receives: Biological: OTS-412 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ANC(absolute neutrophil count) over time
Measured: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16
Changes in lymphocytes count over time
Measured: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16
Secondary outcomes (1)
FLow cytometry
CD surface subtyping for each sampling
Measured: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start4 Jan 2022
- Primary completion14 Jan 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionoxx Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302945
- Sponsor's protocol ID
- OTS412-HV
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Immune Dynamics Following OTS-412 Oncolytic Vaccinia Virus Administration in a Healthy Volunteer(Self-experiment)
- ClinicalTrials.gov ID
- NCT07302945
- Acronym / sponsor ID
- OTS412-HV
- Conditions
- Healthy Volunteer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bionoxx Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OV Treated healthy arm | Experimental | Biological: OTS-412 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A healthy adult
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTS-412After hospitalization, OTS-412 was infused for one hour. | Biological | OV Treated healthy arm |
Primary outcome
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
1 secondary outcome
FLow cytometry
Time frame: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OTS-412 in people with Healthy Volunteer, run by Bionoxx Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.