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NCT06669403 · ClinicalTrials.gov registry record · Phase 1
OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
A Phase 1 study, sponsored by Op-T.
- Not yet
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT06669403: Clinical Trial Phase 1 study, sponsored by Op-T.
NCT06669403 is a Phase 1 study that has not yet begun recruiting, run by Op-T. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06669403, a Phase 1 study, has not yet begun recruiting, sponsored by Op-T.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
OPT101-100-40 is a multicenter, randomized, placebo-controlled, multiple-ascending-dose, sequential-group, investigator- and participant-blinded, sponsor-unblinded, study of OPT101 vs placebo when administered for up to 4 days to patients admitted to the hospital for treatment of Community Acquired Pneumonia (CAP) with sepsis. This study will be performed in patients with Community Acquired Pneumonia (CAP) with Sepsis, who are 18 years or older to evaluate the safety and tolerability of OPT101 in a population with elevated levels of pathologic CD40.
Primary Outcome
Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0
Interventions
- OTHER Placebo
- DRUG OPT101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2025-12 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What is known before NCT06669403 opens enrollment
NCT06669403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06669403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06669403 about?
NCT06669403 is a clinical study titled "OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis". OPT101-100-40 is a multicenter, randomized, placebo-controlled, multiple-ascending-dose, sequential-group, investigator- and participant-blinded, sponsor-unblinded, study of OPT101 vs placebo when administered for up to 4 days to patients admitted to the hospital for treatment of Community Acquired ...
What is the current status of trial NCT06669403?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2025-12. Estimated completion is 2026-05.
What interventions are being tested in trial NCT06669403?
The interventions under investigation include: Placebo (OTHER), OPT101 (DRUG).
Who is sponsoring clinical trial NCT06669403?
This trial is sponsored by Op-T, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06669403's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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