Safety and Tolerability Study of rAvPAL-PEG to Treat Phenylketonuria

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

October 31, 2009

Conditions
Phenylketonuria
Interventions
DRUG

rAvPAL-PEG

rAvPAL-PEG will be administered as a single, SC injection at dose levels of 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0 mg/kg. The duration of treatment is a single dose of study drug with 42 days (6 weeks) of follow-up.

Trial Locations (8)

10029

Mount Sinai Medical Center, New York

15213

University of Pittsburgh, Pittsburgh

53705

University of Wisconsin, Madison

55455

University of Minnesota Medical Center-Fairview, Minneapolis

60614

Children's Memorial Hospital, Chicago

63110

Washington University Center for Applied Research Sciences, St Louis

84132

University of Utah Hospital, Salt Lake City

97239

Oregon Health & Science University, Portland

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY