drugset / Trial / NCT00634660
Safety and Tolerability Study of rAvPAL-PEG to Treat Phenylketonuria
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the safety and tolerability of injections of rAvPAL-PEG in subjects with PKU.
Timeline
- Start
- 2008-05
- Primary completion
- 2009-04
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pegvaliase | Protein / enzyme biologic | 0.001 mg/kg | Subcutaneous |
| Comparator | Pegvaliase | Protein / enzyme biologic | 0.003 mg/kg | Subcutaneous |
| Comparator | Pegvaliase | Protein / enzyme biologic | 0.01 mg/kg | Subcutaneous |
| Comparator | Pegvaliase | Protein / enzyme biologic | 0.03 mg/kg | Subcutaneous |
| Comparator | Pegvaliase | Protein / enzyme biologic | 0.1 mg/kg | Subcutaneous |
| Comparator | Pegvaliase | Protein / enzyme biologic | 0.3 mg/kg | Subcutaneous |
| Comparator | Pegvaliase | Protein / enzyme biologic | 1 mg/kg | Subcutaneous |