This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up. The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects. The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
Sterile saline for injection
Dr. Vince Clinical Research
Overland Park, Kansas, United States
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
Incidence, intensity, and causality of adverse events
Time frame: 5 months
Clinical laboratory assessments
Hematology, biochemistry, and urinalysis
Time frame: 5 months
Vital signs
Blood pressure and pulse rate
Time frame: 5 months
12-Lead electrocardiogram
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Time frame: 5 months
Physical examination
Complete physical examination, assessing the subject's overall health and physical condition
Time frame: 5 months
Infusion site examination
Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
Time frame: 6 days
Cmax
Maximum serum concentration
Time frame: 4 months
AUCinf
Area under the curve from time zero extrapolated to infinity
Time frame: 4 months
AUClast
Area under the curve from time zero to the last measurable concentration
Time frame: 4 months
Tmax
Time to maximum serum concentration
Time frame: 4 months
t1/2
beta terminal elimination half-life
Time frame: 4 months
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