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NCT06283459 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2
A Phase 1 study, sponsored by Imunon.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT06283459: Completed Phase 1 study, sponsored by Imunon.
NCT06283459 is a Phase 1 study that has completed, run by Imunon. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06283459, a Phase 1 study, has completed, sponsored by Imunon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).
Primary Outcome
Local and systemic reactogenicity signs and symptoms for a minimum of seven days following receipt of study product. Laboratory measures of safety. All adverse events (AEs) for thirty days after receipt of study vaccination. All serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events of special interest (AESIs), and AEs leading to early participant withdrawal or permanent discontinuation will be collected throughout the study.
Interventions
- BIOLOGICAL IMNN-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-03-07 |
| Phase | Phase 1 |
What the finished NCT06283459 record still lists
NCT06283459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which IMNN-101 is the first listed.
NCT06283459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06283459 about?
NCT06283459 is a clinical study titled "Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2". This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).
What is the current status of trial NCT06283459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-06-04. Estimated completion is 2025-03-07.
What interventions are being tested in trial NCT06283459?
The interventions under investigation include: IMNN-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06283459?
This trial is sponsored by Imunon, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06283459's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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