Clinical Trial

OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

Not Yet Recruiting Phase 1
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Record status
This record was last updated September 15, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-30; most recent amendment 2025-09-08.
Trial Details
NCT Number NCT06669403
Lead Sponsor Op-T LLC
Conditions Sepsis, Community Acquired Pneumonia (CAP)
Enrollment 26 participants
Start Date 2025-12
Primary Completion 2026-04 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-09-15