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

NCT03974685 | Completed Phase 1

• 1 other identifier: FSRDA201801
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

99mTc-3PRGD2; Integrin ανβ3; Dosimetry

Outcome Measures

Primary Outcomes (5)

• AUC(0-t)

  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)

  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)

  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

  The internal radiation dosimetry (Dt,mSv) of each irradiated organ is calculated.

  post-intervention at 4 months

• Radiochemical purity

  To reflects the stability of the drug in the human body,that Radiochemical purity in urine and blood samples is measured.

  During procedure

Secondary Outcomes (1)

• Incidence of adverse events

  3 days

Study Arms (1)

99mTc-3PRGD2

EXPERIMENTAL

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)

Interventions

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

Single dose

99mTc-3PRGD2

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDO Pharm.: lead
• Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.: collaborator
• MedAlly Solutions Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Study Officials

• Zhaohui Zhu, professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment drug:0.3mCi/kg

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 5, 2019
• Study Start: December 12, 2018
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)