Status:
COMPLETED
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456
Lead Sponsor:
Fresenius Kabi SwissBioSim GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Healthy male and female subjects, 18 to 55 years of age, with a body mass index (BMI) between 18 and 29.9 kilogram per meter square (kg/m\^2).
- Subjects who are on adequate contraception as defined in the protocol and are willing and able to comply with the scheduled study visits, Investigational medicinal product (IMP) administration, safety laboratory tests, and all other study procedures.
- Other protocol defined inclusion criteria could apply.
Exclusion
- Subjects with history and/or current presence of clinically significant atopic allergy (for example, asthma including childhood asthma, urticaria, angio-edema, eczematous dermatitis).
- Subjects with hypersensitivity or allergic reactions, including known or suspected clinically relevant drug hypersensitivity to any components of the IMP formulations, comparable drugs, or to latex.
- Subjects who have active or latent tuberculosis as indicated by a positive QuantiFERON®-Tuberculosis (TB) Gold test or a history of tuberculosis, lifetime history of invasive systemic fungal infections (for example, histoplasmosis) or other opportunistic infections, including recurrent or chronic local fungal infections, frequent (more than 3 per year requiring treatment) chronic or recurrent infections, having previously been treated with tocilizumab or taken a recombinant monoclonal antibody.
- Subjects who have received a live vaccine within 12 weeks before enrolling in this study or planning for any such vaccination during the study or within 4 months after IMP administration.
- Other protocol defined exclusion criteria could apply.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT03282851
Start Date
November 27 2017
End Date
October 1 2019
Last Update
February 12 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Research site
Auckland, New Zealand
2
Research site
Christchurch, New Zealand