drugset / Trial / NCT01478399
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function. Secondary objectives: To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.
Timeline
- Start
- 2011-12
- Primary completion
- 2012-10
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Froniglutide | Protein / enzyme biologic | 90 mg | Subcutaneous |