drugset / Trial / NCT02912377

Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

NCT02912377

Phase 1 Completed 96 enrolled Cinfa Biotech
RandomizedCrossoverTriple-blindTreatment

Summary

Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects

Timeline

Start
2016-09
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic

Indications

No indication recorded.