Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

• Status: Completed
• Trial end date: 2018-10-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH; Merck KGaA

Criteria

Inclusion Criteria:

• Subjects who provide signed and dated written informed consent

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455, and laboratory test results within predefined ranges

• Other protocol defined exclusion criteria could apply.