Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Saline Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Marval Pharma Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Saline Placebo
2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion
Intervention: Saline Placebo
NCTX
6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion
Intervention: NCTX (PEGylated Liposomal Iodixanol Injection)
Outcomes
Primary Outcomes
Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
Time Frame: Baseline and up to and including 28 days post drug administration
Secondary Outcomes
- 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)