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Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

NCT03251248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2019-07-02

No results posted yet for this study

Summary

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.

Conditions

  • Healthy

Interventions

DRUG

MSB11455

Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.

DRUG

Neulasta

Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Principal Investigators

  • Radmila Kanceva, MD, PhD · Fresenius Kabi SwissBioSim GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2018-05-08
Completion
2018-10-17
FDA Drug
Yes

Countries

  • Australia

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 NCT03251248 on ClinicalTrials.gov