Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)

Study Overview
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Brief Summary
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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.

Official Title
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An Intravenous, Single Dose Safety, Tolerance and Pharmacokinetic Study of GE-145 in Healthy Volunteers Undergoing a Contrast-enhanced Abdominal Computed Tomography (CT) Scan

Conditions
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Healthy

Intervention / Treatment
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* Drug: GE-145 (AN113111) Injection
* Drug: Visipaque (iodixanol) Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females between 18 and 60 years of age. For women who are either surgically sterile or are postmenopausal, enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine HCG pregnancy test (with the result known on the day of and before IMP administration) must be negative. Subjects are able and willing to comply with study procedures and sign an informed consent. Exclusion Criteria: Known history of a reaction to any iodinated-based contrast agent or with multiple allergies (i.e. foods, pets, medications, etc). Subjects receiving any medication for which the use of an iodinated contrast agent is contraindicated (i.e.. metformin). Subjects with suspicion or diagnosis of hyperthyroidism. Women that are breastfeeding at the screening and/or enrolment period. Usage of any non-FDA-approved pharmaceutical or therapy within 30 days prior to screening or enrolment in another clinical study within 30 days prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 (AH113111 Injection)<br> | Drug: GE-145 (AN113111) Injection<br>* 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.<br>* Other names: GE-145;|
| Active Comparator: 2 (Visipaque Injection)<br>An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg. | Drug: Visipaque (iodixanol) Injection<br>* An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.<br>* Other names: Iodixanol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours. | 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 | 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. | 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 | 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 | Pre and post contrast administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HU - Hounsfield Units, CECT - Contrast-enhanced computed tomography, HCG - Human Chorionic Gonadotropin, Patient Safety, Tolerance, Pharmacokinetic