Status:
COMPLETED
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
Lead Sponsor:
Fresenius Kabi SwissBioSim GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.
Eligibility Criteria
Inclusion
- Subjects who provide signed and dated written informed consent
- Other protocol defined inclusion criteria could apply
Exclusion
- 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.
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2018
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT03251248
Start Date
August 22 2017
End Date
October 17 2018
Last Update
July 2 2019
Active Locations (2)
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1
Nucleus Network
Melbourne, Victoria, Australia, 3004
2
Q-Pharm Pty Ltd
Herston, Australia, 4006