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 (ALVOPAD FIRST)-Reference-Cited by-同舟云学术

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 (ALVOPAD FIRST)

Published:2022-02-10 Issue:9 Volume:31 Page:965-976
ISSN:1354-3784
Container-title:Expert Opinion on Investigational Drugs
language:en
Short-container-title:Expert Opinion on Investigational Drugs

Author:

Wynne Christopher¹,Schwabe Christian²,Lemech Charlotte³,Stroissnig Heimo⁴,Dias Roshan⁵,Sobierska Joanna⁵,Guenzi Eric⁴,Otto Hendrik⁴,Sattar Abid⁶,Kay Richard⁷,Haliduola Halimu N.⁴,Berti Fausto⁵

Affiliation:

1. New Zealand Clinical Research, Christchurch, New Zealand

2. New Zealand Clinical Research, Auckland, New Zealand

3. Scientia Clinical Research, NSW, Australia

4. Alvotech Germany GmbH, Jülich, Germany

5. Alvotech Swiss AG, Zürich, Switzerland

6. Alvotech UK Ltd, London, UK

7. RK Statistics Ltd, Bakewell, UK

Funder

This study was funded by Alvotech

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/13543784.2022.2035359

Reference43 articles.

1. Humira Prescribing information. Available from: https://www.rxabbvie.com/pdf/humira.pdf [cited 2021 Dec]

2. Humira. Summary of product characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_en.pdf [cited 2021 Dec]

3. Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis

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