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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
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.
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.
Denver Health and Hospital Authority
Denver, Colorado, United States
Incidence of treatment-emergent adverse events (TEAEs)
Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0
Time frame: 30 days
Incidence of serious adverse events (SAEs)
SAEs will be recorded and assessed by CTCAE v4.0
Time frame: 30 days
Incidence of TEAEs leading to study drug discontinuation
Time frame: 30 days
Incidence and characteristics of presumed infusion reactions
Recorded as an adverse event
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine AUCO-24
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Cmax
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Tmax
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine t1/2
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Vz/F
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Time frame: 30 days