A Study of 99mTc-3PRGD2 Injection in Healthy Volunteers

August 7, 2019 updated by: RDO Pharm.

Phase I Open Label Trial of Pharmacokinetics and Safety of 99mTc Niacinamide Polyethylene Glycol Bicyclic RGD Peptide (99mTc-3PRGD2) Injection in Healthy Volunteers

The study drug 99mTc-3PRGD2 of this study is a new radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging.

After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and tumor tissue is developed by SPECT/CT, which can be used for molecular imaging diagnosis and individualized treatment of common tumors.

The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.

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.

Detailed Description

To a large extent, cancer treatment outcomes depend on the accurate diagnosis and staging of the disease. An important basis for early diagnosis of malignant tumors is medical imaging. Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) are most well-developed nuclear medicine procedures based on the measurement of radiolabeled tracer molecules.

These radiotracers allow biologic processes to be measured and whole body images to be obtained, which will demonstrate exact locations of radiotracer accumulation. Functional imagings of SPECT and PET provide specific information which is not available from standard medical imaging modalities such as ultrasound, X-ray, computerized tomography (CT) or magnetic resonance imaging (MRI).

The test drug in this study is a new radioactive diagnostic preparation, consisting of radiochemical (Sodium Pertecheetate [99mTc] Injection) and a kit (including Three core ligands, HYNIC-3PRGD2, Tricine, TPPTS). Before administration, 99mTc:HYNIC-3PRGD2:Tricine:TPPTS (1:1:1:1) chelate compound (99mTc-3PRGD2) will be prepared as per standard opration presedure, which will be used as a molecular probe for SPECT/CT imaging.

The core ligand HYNIC-3PRGD2 is a novel RGD dimer that specifically binds to the integrin αvβ3 receptor with high selectivity and affinity. Integrin αvβ3 is highly expressed in tumor neovascularization. After injection, 99mTc-3PRGD2 will be specifically taken up by the integrin receptor-positive tumor tissue, then be imaged by SPECT/CT. The product can be used for molecular imaging diagnosis and individualized treatment for common tumors such as lung cancer and breast cancer are performed.

The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.

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.
10

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.
  • 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
      • Beijing, China
        • Peking Union Medical College 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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers;
  • 25 to 45 years of age, male to female ratio 1:1;
  • Body mass index (BMI) ranges from 19 to 25 kg/m2 [Body mass index = body weight (kg)/ height squared (m2)];
  • Clinical laboratory test results are normal, or laboratory values out of normal range is judged as not relevant for the clinical trial by the investigator;
  • Subjects should read, sign an Informed Consent Form and willing to complete the trial according to the regulations.

Exclusion Criteria:

  • Women who are breastfeeding or pregnant;
  • Subjects with primary lesion in important organs;
  • Subjects with mental or physical disorders;
  • History of alcohol abuse or drug abuse;
  • Subjects addict to coffee or smoker;
  • Positive result on tests for HIV antibody, HbsAg or anti-hepatitis C virus antibody;
  • History of allergic reactions to two or more kinds of drugs or foods or allergic to any components of test drug;
  • Subjects with diseases (such as insomnia) are receiving other preventive/therapeutic drugs prior to study administration;
  • Other reasons which, in the opinion of the investigator, would prevent the subject from participating in the study;
  • Any anticipation in other clinical trial within 3 months;
  • Subject received isotope treatment or examination before screening, or received X-ray examination more than three times within one year.

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: N/A
  • Interventional Model: Single Group 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: 99mTc-3PRGD2
Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：99mTc niacinamide polyethylene glycol bicyclic RGD peptide dosage form:Injection dosage:0.3mCi/kg frequency:single
Drug: 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)
Single dose

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
AUC(0-t)
Time Frame: Day 1(dosing day )and Pre-dose,1,2,3,19,33,53,91,120,245 minutes post dose
Area under the Activity-time curve from Hour 0 to the last measurable activity
Day 1(dosing day )and Pre-dose,1,2,3,19,33,53,91,120,245 minutes post dose
The %ID(The radioactivity of the urine at each time period/ the total injection activity)
Time Frame: Day 1(dosing day)and Pre-dose,0-50 minutes,50-120 minutes,2-4 hours, 4-8 hours,8-12 hours,12-24hours post dose
The %ID(The radioactivity of the urine at each time period/ the total injection activity) is calculated
Day 1(dosing day)and Pre-dose,0-50 minutes,50-120 minutes,2-4 hours, 4-8 hours,8-12 hours,12-24hours post dose
The %ID(The radioactivity of the main organs at each time period/ the total injection activity)
Time Frame: post-intervention at 4 months
The %ID(The radioactivity of the main organs at each time period/ the total injection activity) is calculated.
post-intervention at 4 months
The radiation dosimetry of the test drug in organs
Time Frame: post-intervention at 4 months
The internal radiation dosimetry (Dt,mSv) of each irradiated organ is calculated.
post-intervention at 4 months
Radiochemical purity
Time Frame: During procedure
To reflects the stability of the drug in the human body,that Radiochemical purity in urine and blood samples is measured.
During procedure

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
Incidence of adverse events
Time Frame: 3 days
Assessment of adverse events
3 days

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.
RDO Pharm.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.
MedAlly Solutions 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.
December 12, 2018

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.
January 18, 2019

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.
January 18, 2019

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).
May 16, 2019

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.
May 31, 2019

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.
June 5, 2019

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 8, 2019

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 7, 2019

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.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • FSRDA201801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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