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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
OPT101
DrugOPT101, 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.
Placebo
Other intervention0.9% 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.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: 0.9% Sodium Chloride Injection USPPlacebo comparator 1 intervention
Group B: OPT101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (TEAEs)
Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0
Time frame
30 days2
Incidence of serious adverse events (SAEs)
SAEs will be recorded and assessed by CTCAE v4.0
Time frame
30 days3
Incidence of TEAEs leading to study drug discontinuation
Time frame
30 days4
Incidence and characteristics of presumed infusion reactions
Recorded as an adverse event
Time frame
30 daysSecondary outcomes
1
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine AUCO-24
Time frame
30 days2
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Cmax
Time frame
30 days3
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Tmax
Time frame
30 days4
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine t1/2
Time frame
30 daysOther outcomes
1
To observe the changes in degree of sepsis via Pneumonia Severity Index (PSI)
Pneumonia Severity Index (PSI) predicts the need for hospitalization for people with Community Acquired Pneumonia (CAP). Patients are ranked by Risk Class (I , II, III, IV or V). Patients with CAP categorized as Risk Class of I and II can be treated at home. Patients with CAP categorized as Risk Class III may be treated at home or may require a short hospital stay. Patients with CAP categorized as Risk Class of IV and V require hospitalization.
Time frame
30 days2
To observe the changes in degree of sepsis via Sequential Organ Failure Assessment (SOFA) score
SOFA grading, minimum value is 0 (normal) and maximum value is 4 (highest degree of dysfunction/failure). The higher the score, the worse the outcome.
Time frame
30 days3
To observe the changes in degree of sepsis via Cytokine Release Syndrome (CRS) grading
CRS is graded from Grade 1 to Grade 4. Grade 1 is the best outcome and Grade 4 is the worst outcome in terms of change in degree of sepsis. CRS parameters used for grading include fever, hypotension and hypoxia.
Time frame
30 days4
Evaluate Pharmacodynamic Effects of OPT101
Quantitation of Th40 to Treg ratio
Time frame
30 days Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: