Status:
COMPLETED
Safety and Immunogenicity of MSB11455 in Healthy Participants
Lead Sponsor:
Fresenius Kabi SwissBioSim GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.
Eligibility Criteria
Inclusion
- 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
- Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.
- Other protocol defined exclusion criteria could apply.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2018
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT03251339
Start Date
August 21 2017
End Date
September 22 2018
Last Update
July 2 2019
Active Locations (2)
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1
Auckland Clinical Studies Ltd
Auckland, New Zealand, 1150
2
Christchurch Clinical Studies Trust
Christchurch, New Zealand, 8001