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

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

Interventional

Enrollment (Actual)

10

Phase

  • 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

      • 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

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
Intervention / Treatment
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
Single dose

What is the study measuring?

Primary Outcome Measures

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

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.

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)

December 12, 2018

Primary Completion (Actual)

January 18, 2019

Study Completion (Actual)

January 18, 2019

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

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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