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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02063594

Enrollment

Registered

2014-02-14

Start date

2014-03-31

Completion date

2014-10-31

Last updated

2014-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Iodixanol, Iodinated Contrast, Liposome, Computed Tomography, X-ray Imaging, Blood pool agent, Biomarker

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.

Interventions

DRUGNCTX (PEGylated Liposomal Iodixanol Injection)

Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg

DRUGSaline Placebo

Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026