Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers

Study Overview
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Brief Summary
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This is a randomized, double-blind, single dose, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection) administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans will be acquired to measure radiographic density in regions of interest (ROI) at times from 3-5 hours and up to 72 hours following NCTX administration.

Official Title
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Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: NCTX (PEGylated Liposomal Iodixanol Injection)
* Drug: Saline Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, nonsmoking men and women 18 to 55 years of age Body Mass Index (BMI) between 18.5 and 30.0 kg/m2 Serum creatinine within normal range and calculated creatinine clearance of 80 mL/min/1.73 m2 or greater Exclusion Criteria: Concurrent enrollment in another clinical trial or treatment with any investigational products or therapies within 30 days prior to dosing History of infusion reactions to liposomes, nanoparticles, monoclonal antibodies, or intravenously administered materials History of allergic/anaphylactoid-like reactions attributed to iodinated contrast agents or other components of the formulation Disturbances in normal fat metabolism, or total cholesterol greater than 240 mg/dL Pregnant or nursing women Exposure to significant radiation within 1 year, or previous CT scan within 5 years prior to check-in

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline Placebo<br>2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion | Drug: Saline Placebo<br>* Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug<br>|
| Experimental: NCTX<br>6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion | Drug: NCTX (PEGylated Liposomal Iodixanol Injection)<br>* Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg<br>* Other names: NCTX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring |  | Baseline and up to and including 28 days post drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol |  | Baseline and up to 28 days post drug administration | 
| Radiographic density in ROIs by abdominal CT imaging |  | From 3-5 hours and up to 72 hours following NCTX administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iodixanol, Iodinated Contrast, Liposome, Computed Tomography, X-ray Imaging, Blood pool agent, Biomarker