Trials / Completed
CompletedNCT02629562
Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects
Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- Cinfa Biotech · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | B12019 and Neulasta | GCSF, Growth Colony Stimulating Factor |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-07-01
- First posted
- 2015-12-14
- Last updated
- 2017-10-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02629562. Inclusion in this directory is not an endorsement.