Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

NCT00594698 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2008-07-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.

Conditions

Interventions

DRUG

PB127 for injectable suspension

0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes

Sponsors & Collaborators

  • Point Biomedical

    lead INDUSTRY

Principal Investigators

  • Alexander Ehlgen, MD, PhD · POINT Biomedical Corp.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2003-09-30
Completion
2003-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT00594698 on ClinicalTrials.gov