Familiarization and Safety Study of PB127 Ultrasound Contrast Agent
NCT00594698 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2008-07-03
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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