Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.

Official Title
-----------------
A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Ioforminol 160 mgI/mL
* Drug: Ioforminol 200 mgI/mL
* Drug: Iopamidol 300 mgI/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females between 18 and 50 years of age. The subject has a maximum abdominal circumference of 120 cm or less. Exclusion Criteria: The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc). The subject has chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <60 mg/dL) as measured at the screening visit. The subject is pregnant or breast-feeding. The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone. The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency. The subject is taking metformin (e.g., Glucophage®) therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Ioforminol 160mgI/mL<br>Single administration of Ioforminol 160mgI/mL given to the subject. | Drug: Ioforminol 160 mgI/mL<br>* Given as s single administration to the subject<br>* Other names: Ioforminol;|
| Experimental: Arm 2 - Ioforminol 200mgI/mL<br>Given as a single administration to the subject | Drug: Ioforminol 200 mgI/mL<br>* Given as a single administration to the subject<br>* Other names: Ioforminol;|
| Active Comparator: Arm 3 - Iopamidol 300mgI/mL<br>Given as a single administration to the subject | Drug: Iopamidol 300 mgI/mL<br>* Given as a single administration to the subject<br>* Other names: Isovue;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. | Within 5 minutes after administration for either Ioforminol or Iopamidol. | 
| Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. | Within 5 minutes after administration for either Ioforminol or Iopamidol. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Recording the occurrence of treatment emergent adverse events (TEAE). | Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Use in Abdominal, Contrast Enhanced, Computed Tomography, Optimize concentration, dosage of Ioforminol Injection