Safety and Immunogenicity of MSB11455 in Healthy Participants

• Status: Completed
• Trial end date: 2018-09-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.

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

Details

• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH; Merck KGaA

Criteria

Inclusion Criteria:

• Participants who provide signed and dated written informed consent.

• Participants with laboratory test results within predefined ranges.

• Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

• Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.

• Other protocol defined exclusion criteria could apply.