OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis (NCT06669403) | Clinical Trial Compass
Not Yet RecruitingPhase 1
OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
United States26 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed).
ā. ā„18 years old;
ā. 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:
ā. Need for non-invasive supplemental oxygen (nasal cannula, simple mask, venturi or reservoir cannula/mask or heated high flow nasal cannula oxygen.
ā. Females of child-bearing potential who are sexually active must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:
Exclusion criteria
ā. Need for endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at time of study screening
ā. QTc ā„ 450 msec on screening ECG
ā. Hepatic dysfunction: ALT or AST \> 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score ā„ 12)
What they're measuring
1
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: 30 days
2
Incidence of serious adverse events (SAEs)
Timeframe: 30 days
3
Incidence of TEAEs leading to study drug discontinuation
Timeframe: 30 days
4
Incidence and characteristics of presumed infusion reactions
ā. Recent or active hepatitis A infection; test positive or have been treated for hepatitis B, hepatitis C, or HIV infection; evidence of active or untreated latent TB; a recent history of recurrent herpes zoster and/or opportunistic infection; and/or taking immunosuppressant medication.
ā. Renal dysfunction: estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73 m2, or need for hemodialysis or hemofiltration
ā. Current use of \>2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC \< local LLN), solid organ or bone marrow transplant recipients)
ā. Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period
ā. Anticipated discharge from the hospital or transfer to another hospital within 48 hours of screening