Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
HealthyCoronary Artery Disease
Interventions
DRUG

PB127 for Injectable Suspension

"Stages 1 \& 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less.~Stage 3 - will utilize infusion rate and dose established in Stages 1 \& 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions."

Trial Locations (16)

15213

University of Pittsburgh Cardiovascular Institute, Pittsburgh

19713

Alfieri Cardiology, Newark

44195

The Cleveland Clinic Foundation, Cleveland

60637

University of Chicago Medical Center, Chicago

63110

St. Louis University Medical Center, St Louis

64111

Cardiovascular Consultants, Kansas City

66204

The Center for Cardiovascular Studies Kramer and Crouse Cardiology, Shawnee Mission

66209

Midwest Cardiology Associates, Overland Park

78701

Seton Healthcare Network Brackenridge Hospital, Austin

78705

Austin Heart, Austin

90822

Long Beach VA Medical Center Cardiology Division, Long Beach

92103

University of California San Diego Division of Cardiology, San Diego

97239

Oregon Health Sciences University, Portland

99204

Inland Cardiology, Spokane

Northwest Cardiovascular Research Institute Spokane Cardiology, Spokane

04210

Androscoggin Cardiovascular Associates, Auburn

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Point Biomedical

INDUSTRY