Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects

NCT02744248 | Completed Phase 1 DMC

• 2 other identifiers: CEECTTA20100721IOP-CT-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects. Secondary:

1. 1.To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects.
2. 2.To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.
3. 3.To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy subjects.

Conditions

Magnetic Resonance Imaging

Keywords

Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLTs) of IOP

  DLT is defined as any grade 2 or above toxicity by NCI-CTCAE version 4.03, as determined by the investigator and sponsor, to be at least possibly related in causality to the administered investigational product IOP

  Up to 14 days post-IOP injection

• Maximum tolerated dose (MTD) of IOP

  MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities

  Up to 14 days post-IOP injection

Secondary Outcomes (6)

• Pharmacokinetic parameters-Cmax

  Up to 3 days post-IOP injection

• Pharmacokinetic parameters-Tmax

  Up to 3 days post-IOP injection

• Pharmacokinetic parameters-AUC0-t

  Up to 3 days post-IOP injection

• Pharmacokinetic parameters-AUC0-inf

  Up to 3 days post-IOP injection

• Pharmacokinetic parameters-T1/2

  Up to 3 days post-IOP injection

Study Arms (2)

IOP Injection

ACTIVE COMPARATOR

Participants will receive 1 injection of the IOP at Days 1,once time.

Drug: IOP Injection

0.9% normal saline

PLACEBO COMPARATOR

Participants will receive 1 injection of 0.9% normal saline at Days 1,once time.

Drug: 0.9% normal saline

Interventions

IOP Injection DRUG

IOP Injection 20 mg Fe/ml, intravenous injection

Also known as: Iron oxide nano particle m-PEG-silane

IOP Injection

0.9% normal saline DRUG

0.9% normal saline 10 ml, intravenous injection

Also known as: Sodium Chloride

0.9% normal saline

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, age ≥ 20 \~40 years old with BMI between 18 and 27.
• Subject must be in good general health condition (i.e., full physical examinations, medical history, vital signs, ECG, and clinical laboratory tests performed at screening) as determined by the investigator. Normal ECG is defined as normal cardiac conduction parameters including resting heart rate between 50 and 100 bpm, Fridericia-corrected QT interval (QTcF) ≤ 450 milliseconds, and QRS interval \< 120 milliseconds.
• Subject shows normal biochemistry test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
• Blood urea nitrogen (BUN), creatinine, and uric acid.
• Albumin and total protein.
• Alkaline phosphatase, ALT,AST, and total bilirubin.
• Serum iron, total iron-binding capacity, serum ferritin,percent transferrin saturation (TSAT), and transferrin.
• Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Antibody HBsAg (anti-HBs),and antibodies against HCV (anti-HCV).
• Subject shows normal complete blood count (CBC) test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
• Red blood cell (RBC) count and reticulocyte count.
• White blood cell (WBC) count with differential.
• Hemoglobin and hematocrit.
• Platelet count.
• Subject shows normal urinalysis test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
• pH, color, appearance, and gravity

You may not qualify if:

• Subjects have serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e.,Gd-based and SPIO particles contrast agents).
• Subjects have been diagnosed of Hepatitis B or C, venereal disease laboratory screens or have been determined of positive result of human immunodeficiency virus test.
• Imaging and/or functional abnormalities of liver and/or spleen. That is,
• Subjects have been diagnosed of abnormal liver function and appearances through medical histories, clinical laboratory tests, and imaging test including mild fatty liver, iron deposition or any acute/chronic liver change.
• Subjects have signs of splenomegaly, enlargement of the spleen, or clinical laboratory tests showing signs of spleen functional abnormalities.
• Subjects have been performed with any examinations with contrast agents applied within 28 days before study.
• Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
• Subjects are unable to undergo an MRI scan.
• Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers,insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.
• Subjects have participated in other investigational trials within 28 days prior to study enrollment.
• Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action,adequate absorption and elimination of investigational contrast agent.
• Subjects have taken any food 6 hours prior to administration.
• Subject with conditions judged by the investigator as unsuitable for the study.

Sponsors & Collaborators

• MegaPro Biomedical Co. Ltd.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rheun-Chuan Lee

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 20, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

TW (1)