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

NCT03974685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-08

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

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

Single dose

Sponsors & Collaborators

  • Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.

    collaborator INDUSTRY

  • MedAlly Solutions Co., Ltd.

    collaborator UNKNOWN

  • RDO Pharm.

    lead INDUSTRY

Principal Investigators

  • Zhaohui Zhu, professor · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2019-01-18
Completion
2019-01-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974685 on ClinicalTrials.gov