OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOp-T LLC
About this trial
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 criteria
Qualifiers
Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed).
≥18 years old;
respiratory rate > 30 breaths/min;
fever (> 38.0°C or > 100.4° F);
Disqualifiers
Need for endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at time of study screening
QTc ≥ 450 msec on screening ECG
Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score ≥ 12)
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.
Trial design
Treatments tested in this trial
- OPT101
- Placebo
Treatment groups
26 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov