drugset / Trial / NCT01478399

Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function

NCT01478399

Phase 1 Completed 16 enrolled PhaseBio Pharmaceuticals Inc.
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

EvaluationDrugModalityDoseRoute
Subject Froniglutide Protein / enzyme biologic 90 mg Subcutaneous