A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
Op-T LLC
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed). 2. ≥18 years old; 3. Patients hospitalized for clinically suspected community acquired pneumonia (CAP), defined as the occurrence of (within 48h from hospital admission) at least 1 of the following signs: * respiratory rate \> 30 breaths/min; * fever (\> 38.0°C or \> 100.4° F); * leukopenia (≤ 4,000 WBC/mm3 or leukocytosis (≥ 12,000 WBC/mm3); * adults ≥ 70 years of age; altered mental status with no other recognized cause; AND…
Interventions
- DrugOPT101
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.
- OtherPlacebo
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.
Location
- Denver Health and Hospital AuthorityDenver, Colorado