NCT02912377

Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Cinfa Biotech · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Neulasta, B12019	GCSF, Growth Colony Stimulating Factor

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-09-23
• Last updated: 2017-05-18

Locations

1 site across 1 country: Germany