MSB11456
DrugSubjects will receive a single injection of MSB11456 on Day 1.
NCT Number: NCT03282851
This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Research site, Auckland, New Zealand
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive a single injection of MSB11456 on Day 1.
Subjects will receive a single injection of US-licensed actemra on Day 1.
Subjects will receive a single injection of EU-approved RoActemra on Day 1.
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Time frame: Up to Day 48
Fresenius Kabi SwissBioSim GmbH
Industry
Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability and Immunogenicity of MSB11456, US-licensed Actemra® and EU-approved RoActemra® in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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