NCT03251248

Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Fresenius Kabi SwissBioSim GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-08-22
• Primary completion: 2018-05-08
• Completion: 2018-10-17
• First posted: 2017-08-16
• Last updated: 2019-07-02

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study