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NCT05216510 · ClinicalTrials.gov registry record · Phase 1
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
A Phase 1 study, sponsored by Tonix Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT05216510: Clinical Trial Phase 1 study, sponsored by Tonix Pharmaceuticals.
NCT05216510 is a Phase 1 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05216510, a Phase 1 study, was terminated before completion, sponsored by Tonix Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
Primary Outcome
The primary efficacy endpoint of this study is the maximal area of induration ≥5 mm at injection sites on the volar aspect of the forearms of 3 time points post skin test administration. The outcome measure is the maximum of the area of induration of 48 hours, 72 hours, and 96 hours.
Interventions
- BIOLOGICAL CANDIN
- BIOLOGICAL TNX-2110
- BIOLOGICAL TNX-2120
- BIOLOGICAL TNX-2130
- BIOLOGICAL Diluent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-01-07 |
| Est. Completion | 2022-09-17 |
| Phase | Phase 1 |
Why NCT05216510 stopped before completion
NCT05216510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which CANDIN is the first listed.
NCT05216510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05216510 about?
NCT05216510 is a clinical study titled "Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens". This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
What is the current status of trial NCT05216510?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2022-01-07. Estimated completion is 2022-09-17.
What interventions are being tested in trial NCT05216510?
The interventions under investigation include: CANDIN (BIOLOGICAL), TNX-2110 (BIOLOGICAL), TNX-2120 (BIOLOGICAL), TNX-2130 (BIOLOGICAL), Diluent (BIOLOGICAL).
Who is sponsoring clinical trial NCT05216510?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05216510's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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