Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Author:

Maurer Marcus12ORCID,Saini Sarbjit S.3ORCID,McLendon Kristi4,Wabnitz Paul5ORCID,Kim Sunghyun6,Ahn Keumyoung6,Kim Suyoung6,Lee Sewon6,Grattan Clive7ORCID

Affiliation:

1. Institute of Allergology Charité – Universitätsmedizin Berlin Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany

2. Allergology and Immunology Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP) Berlin Germany

3. Johns Hopkins University School of Medicine Johns Hopkins University Baltimore Maryland USA

4. Nucleus Network Pty Ltd Herston Queensland Australia

5. cPHARMA Pty Ltd Adelaide South Australia Australia

6. Celltrion, Inc. Incheon Republic of Korea

7. St John's Institute of Dermatology Guy's Hospital London UK

Publisher

Wiley

Subject

Immunology and Allergy,Immunology,Pulmonary and Respiratory Medicine

Reference30 articles.

1. Roles of omalizumab in various allergic diseases

2. European Medicines Agency.Xolair. Summary of Product Characteristics.2021. Accessed July 18 2022.https://www.ema.europa.eu/en/documents/product‐information/xolair‐epar‐product‐information_en.pdf

3. US Food and Drug Administration.Xolair. Prescribing Information.2021. Accessed July 18 2022.https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5239lbl.pdf

4. Global Initiative for Asthma.Global Strategy for Asthma Management and Prevention (2021 Update).2021. Accessed July 18 2022.https://ginasthma.org/wp‐content/uploads/2021/05/GINA‐Main‐Report‐2021‐V2‐WMS.pdf

5. EAACI Biologicals Guidelines—Recommendations for severe asthma

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