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

• Status: Completed
• Trial end date: 2019-01-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RDO Pharm.
• Collaborators: Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.; MedAlly Solutions Co., Ltd.
• Treatments: Arginyl-glycyl-aspartic acid; Niacin; Niacinamide; Nicotinic Acids

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.