This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145 through the evaluation of serum and urine. It will evaluate the radiographic density in regions of interest (ROI) and the overall diagnostic quality following administration of GE-145.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration.
An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
GE Healthcare
Princeton, New Jersey, United States
Blood Urea Nitrogen and Creatinine Serum Values
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Time frame: Baseline and up to and including 72 hours post contrast administration
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic and Diastolic bolld pressure taken up to and including 8 hours
Time frame: Baseline and up to and including 8 hours post contrast administation.
Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values
Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.
Time frame: Baseline and up to and including 8 hours post contrast administration
12-Lead Electrocardiogram (ECG) Values
12-Lead ECG values taken up to and including 24 hours
Time frame: Baseline and up to and including 24 hours post contrast administration
Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image
Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase
Time frame: Pre and post contrast administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.