Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

August 23, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Single-center, Randomized, Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection in Healthy Subjects to Evaluate Magnetic Resonance Imaging in Multiple Dose Groups

This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the test drug for safety evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453000
        • Xinxiang Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signing the informed consent form before the trial and fully understanding the content, process and possible adverse effects of the trial;
  • Be able to complete the study according to the requirements of the trial protocol;
  • Male subjects aged 18 to 40 years old (including the threshold);
  • Subjects weighing no less than 50 kilograms. Body mass index (BMI) = weight (kg)/height2 (m2), BMI within the range of 19~26 (including the critical value);
  • Health status: no mental abnormality, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
  • Vital signs, physical examination, laboratory tests, electrocardiogram and imaging tests are normal or abnormal without clinical significance;
  • No pregnancy and voluntary use of effective contraception for at least 6 months from 2 weeks prior to dosing to the last use of the study drug.

Exclusion Criteria:

  • Previously suffered from neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disorders, or other diseases, and in the judgment of the investigator, the previous medical history may have an impact on the magnetic resonance imaging procedure, the quality of the images, or the safety of the subject;
  • Subjects with internal metal foreign bodies (dentures, contraceptive rings, metal implants, metal clips, etc.) and persons who are claustrophobic;
  • Those who are allergic to the study drug, its metabolites or its excipients;
  • Subjects who have smoked more than 5 cigarettes per day for 3 months prior to the trial;
  • History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol or 150 ml of wine);
  • Blood donation or significant blood loss (> 450 ml) within 2 months prior to dosing;
  • Use of any drug that alters liver enzyme activity (e.g., liver enzyme inhibitors chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver enzyme inducers barbiturates, carbamazepine, rifampicin, dexamethasone, etc.) in the 28 days prior to dosing;
  • Use of any prescription medication, over-the-counter medication, any vitamin product or herbal remedy within 14 days prior to dosing;
  • The need to use tobacco, alcohol and caffeinated beverages, or certain foods that may affect metabolism (e.g., grapefruit, grapefruit juice, etc.) during the trial period, or a significant change in dietary or exercise habits prior to the trial, or any other factor that affects the absorption, distribution, metabolism, or excretion of the drug;
  • Use of an investigational drug or participation in a clinical trial of a drug within 2 months prior to dosing;
  • Screening positive for hepatitis (including hepatitis B and C) and for AIDS and syphilis;
  • Screening positive for drugs or a history of drug abuse within the past 5 years or drug use within the 3 months prior to the trial;
  • Persons who have difficulty with MRI scanning or who cannot tolerate MRI scanning;
  • Acute illness occurring during the pre-study screening phase or prior to study drug administration;
  • Subjects who are unable or incapable of complying with ward regulations.
  • The subject is unable to complete the trial for personal reasons.
  • Other circumstances which, in the judgment of the investigator, make enrollment in the study unsuitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: polyglucose superparamagnetic iron oxide injection 2.5 mg/kg
Intravenous injected polysaccharide superparamagnetic iron oxide injection at 2.5 mg/kg dose;
Drug: polysaccharide superparamagnetic iron oxide injection
Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.
Experimental: polyglucose superparamagnetic iron oxide injection 3.0 mg/kg
Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3.0 mg/kg dose;
Drug: polysaccharide superparamagnetic iron oxide injection
Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: Baseline up to 144 hours
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Baseline up to 144 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contrast-enhanced magnetic resonance angiography (CE-MRA)
Time Frame: Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration.
CE-MRA of the whole heart and large arteries, coronary angiography and contrast-enhanced scan of the upper abdomen, the aorta and its main branches (left and right renal arteries, celiac trunk, superior mesenteric arteries, bilateral iliac arteries) as well as bilateral femoral arteries of the lower limbs will be evaluated
Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YHT-I-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings