drugset / Trial / NCT03206229

Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects

NCT03206229

RandomizedCrossoverDouble-blindTreatment

Summary

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT). All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.

Timeline

Start
2017-02-13
Primary completion
2017-06-02
Completion
2018-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 2 mg Subcutaneous

Indications

No indication recorded.