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NCT04225533 · ClinicalTrials.gov registry record · Phase 1
SP16 Inflammatory Response Inhibition Trial
A Phase 1 study, sponsored by Serpin Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04225533: Completed Phase 1 study, sponsored by Serpin Pharma.
NCT04225533 is a Phase 1 study that has completed, run by Serpin Pharma. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04225533, a Phase 1 study, has completed, sponsored by Serpin Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.
Primary Outcome
This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP.
Interventions
- DRUG SP16
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2021-12-21 |
| Phase | Phase 1 |
What the finished NCT04225533 record still lists
NCT04225533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which SP16 is the first listed.
NCT04225533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04225533 about?
NCT04225533 is a clinical study titled "SP16 Inflammatory Response Inhibition Trial". This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.
What is the current status of trial NCT04225533?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-02-24. Estimated completion is 2021-12-21.
What interventions are being tested in trial NCT04225533?
The interventions under investigation include: SP16 (DRUG).
Who is sponsoring clinical trial NCT04225533?
This trial is sponsored by Serpin Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04225533's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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