NCT06669403

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

A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Op-T LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Community Acquired Pneumonia (CAP)

Interventions

Type	Name	Description
DRUG	OPT101	OPT101, is a 15-mer peptide derived from the sequence of mouse CD40L and was designed to target CD40-mediated inflammation. On the day of administration, the product will be diluted in saline to result in 50 mL for intravenous (IV) infusion over 120 minutes.
OTHER	Placebo	0.9% Sodium Chloride Injection USP, Placebo. On the day of administration, a 50mL IV bag containing saline (0.9% Sodium Chloride Injection USP) which will serve as the placebo will be administered via intravenous (IV) infusion over 120 minutes.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-11-01
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study