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Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

NCT02629562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2017-10-13

No results posted yet for this study

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

  • Clinical Pharmacology

Interventions

BIOLOGICAL

B12019 and Neulasta

GCSF, Growth Colony Stimulating Factor

Sponsors & Collaborators

  • Cinfa Biotech

    lead INDUSTRY

Principal Investigators

  • Michael Lissy, MD · Nuvisan GmbH

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
2015-11-30
Primary Completion
2016-07-31

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 NCT02629562 on ClinicalTrials.gov