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Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

NCT02912377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-05-18

No results posted yet for this study

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

BIOLOGICAL

Neulasta, B12019

GCSF, Growth Colony Stimulating Factor

Sponsors & Collaborators

  • Cinfa Biotech

    lead INDUSTRY

Principal Investigators

  • Michael Lissy, MD · Nuvisan GmbH, 89231 Neu-Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912377 on ClinicalTrials.gov