A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects
| العنوان: | A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects |
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| المؤلفون: | Jingrui Liu, Yanhua Ding, Cuiyun Li, Min Wu, Jixuan Sun, Hong Zhang, Xiaoxue Zhu, Min Fang, Xiaojiao Li |
| المصدر: | Annals of Medicine article-version (VoR) Version of Record |
| بيانات النشر: | Taylor & Francis, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | musculoskeletal diseases, Adult, Male, China, 030204 cardiovascular system & hematology, Pharmacology, immunogenicity, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, Pharmacokinetics, Double-Blind Method, Pregnancy, Medicine, Humans, 030212 general & internal medicine, skin and connective tissue diseases, Biosimilar Pharmaceuticals, inter-subject variability, business.industry, Healthy subjects, Biosimilar, General Medicine, Middle Aged, Healthy Volunteers, Reference product, chemistry, Female, biosimilar, business, pharmacokinetics, Research Article |
| الوصف: | QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects. A randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence of QX003S (8 mg/kg) with that of Actemra® as a reference drug. QX003S (N = 40) and Actemra® (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% to 18.78%. The 90% confidence intervals of the ratios for Cmax, AUC0–t andAUC0–∞ in both groups were within the range of 80–125%. After administration, the number of subjects who tested positive for anti-drug antibodies (ADA) in the QX003S group and Actemra® groups was 6 (14.3%) and 14 (34.1%), respectively. Adverse reactions occurred in 100% and 97.6% subjects in the QX003S and Actemra® groups, respectively. The most common adverse reactions were decrease in fibrinogen level and neutrophil and leukocyte counts. The PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects.Trial RegistrationThe trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002Test)Key pointsThis was the first clinical report of a new proposed tocilizumab biosimilar, QX003S.This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@).The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles. The trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002Test) This was the first clinical report of a new proposed tocilizumab biosimilar, QX003S. This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@). The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles. |
| اللغة: | English |
| تدمد: | 1365-2060 0785-3890 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::86b13c7ca9712f07e3059aa6405788a8Test http://europepmc.org/articles/PMC7919877Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....86b13c7ca9712f07e3059aa6405788a8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 13652060 07853890 |
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