A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.
Purpose: This is the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab biosimilar, with Avastin® sourced from Roche Diagnostics GmbH.Methods: In this double-blind, single-dose, parallel-group study, healthy male subjects were randomized 1:1 to receive QL1101 or Avastin® 3...
| Publicado en: | Cancer Chemotherapy & Pharmacology Vol. 85; no. 3; pp. 555 - 563 |
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| Autores principales: | , , , , , , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Springer Nature
Mar2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=141881503&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 141881503 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 03445704 NO9 jtl: Cancer Chemotherapy & Pharmacology issn: 03445704 maglogo: N pubinfo: dt: Mar2020 vid: 85 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 141881503 141881503 NLM31907645 141881503 10.1007/s00280-019-04014-x NLM31907645 141881503 ppf: 555 ppct: 8 formats: tig: atl: A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects. aug: au: Liu, Ya-nan Huang, Jie Guo, Can Yang, Shuang Ye, Ling Wu, Shu-ting Zhang, Xing-fei Yang, Xiao-yan Han, Cui-cui Pei, Qi Huang, Lu He, Qing-nan Yang, Guo-ping affil: Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China sug: subj: Biological Products Therapeutic Use Young Adult Human Pharmacokinetics Adolescence Administration, Intravenous Methods Adult Male Biological Products Double-Blind Studies Research Subjects Validation Studies Comparative Studies Evaluation Research Multicenter Studies Checklists Scales Adolescent: 13-18 years Adult: 19-44 years Male ab: Purpose: This is the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab biosimilar, with Avastin® sourced from Roche Diagnostics GmbH.Methods: In this double-blind, single-dose, parallel-group study, healthy male subjects were randomized 1:1 to receive QL1101 or Avastin® 3 mg/kg intravenously. Pharmacokinetic assessments were conducted for 85 days, with additional safety and immunogenicity assessments until day 90. Primary study endpoints were area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞), AUC from time zero to the last quantifiable concentration (AUC0-last), and maximum serum concentration (Cmax). Pharmacokinetic equivalence was shown if the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of the C0-max, AUC0-last, and AUC0-∞ were within the predefined bioequivalence margin of 80-125.00%.Results: A total of 82 subjects were randomized to the following groups: 42 to QL1101 and 40 to Avastin®. The 90% CIs of the GMRs of AUC0-∞, AUC0-last, and Cmax of QL1101 and Avastin® were (97.8%, 107.0%), (94.5%, 106.9%), and (94.1%, 107.3%), respectively, which were all within the bioequivalence margin. The incidence of adverse events was 90.5% and 95.0% in the QL1101 and Avastin® groups, respectively. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups.Conclusions: The study demonstrated the pharmacokinetic equivalence of QL1101 to Avastin®. QL1101 (3 mg/kg, iv) is safe and tolerable in healthy Chinese subjects. These data support the further clinical evaluation of QL1101 as a bevacizumab biosimilar. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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