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

NCT ID: NCT03974685

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2019-01-18

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)

Intervention Type: DRUG

Single dose

Interventions

99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)

Single dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

MedAlly Solutions Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

RDO Pharm.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu, professor

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

FSRDA201801

Identifier Type: -

Identifier Source: org_study_id