drugset / Trial / NCT02629562

Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

NCT02629562

Phase 1 Completed 172 enrolled Cinfa Biotech
RandomizedCrossoverTriple-blindTreatment

Summary

Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.

Timeline

Start
2015-11
Primary completion
2016-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

No indication recorded.