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NZCR is pleased to announce a recent publication in Expert Opinion on Investigational Drugs of a randomized, adaptive design, double- blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02 a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects
In this study, 392 subjects were randomised to show that PK bioequivalence was supported between AVT02, US-licensed- and EU-approved-reference product adalimumab. Similar safety and immunogenicity were also demonstrated.
This trial was completed at both our Auckland and Christchurch sites in 2019. The article was authored by NZCR Principal Investigators, Dr Christopher Wynne and Dr Christian Schwabe.
Dr Chris Wynne said “We are very pleased to have completed this large biosimilar which resulted in quality data enabling a new medication being made available to patients in NZ and around the world.
Please view full article here Full Publication
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New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.