机构：[1]Department of Pharmacy, Peking University People’sHospital, Beijing, China[2]Department of Pharmacy Administration and ClinicalPharmacy, School of Pharmaceutical, Peking University,Beijing, China[3]Department of Pharmacy, Shenzhen Bao’an DistrictSonggang People’s Hospital, Shenzhen, China深圳市康宁医院深圳医学信息中心[4]Phase I Clinical Research Center, The Sixth AffiliatedHospital of Guangzhou Medical University QingyuanPeople’s Hospital, Guangdong, China[5]Comprehensive Chemotherapy Ward, Peking UniversityPeople’s Hospital, Beijing, China[6]Department of Intensive Care Units, Peking UniversityPeople’s Hospital, Beijing, China[7]Department of Pharmacology and Toxicology, BeijingInstitute of Radiation Medicine, Beijing, China[8]Department of Clinical and Registration, Genor BiopharmCo., Ltd., Shanghai, China[9]The Center for Drug Clinical Research of ShanghaiUniversity of TCM, Shanghai, China
The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects.
We conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference infliximab group. Both the test and reference drug were administered as a single intravenous dose of 3 mg/kg. Blood samples were collected as per a designated schedule to evaluate PKs and immunogenicity. Safety was assessed throughout the study. PK similarity was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios of the GB242 to reference infliximab for maximum concentration (Cmax), area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUCt), and AUC from time zero to infinity (AUC∞) were within the predefined bioequivalence range of 80-125%.
The mean serum concentration-time curves were similar between GB242 and reference infliximab. The 90% CIs for the geometric mean ratios of the GB242 to reference infliximab for Cmax, AUCt, and AUC∞ were completely within 80-125% for the PK similarity comparison. The proportion of subjects with treatment-emergent adverse events was similar between the GB242 group and the reference infliximab group. Antidrug antibody profiles were comparable between the two treatments groups.
This study demonstrated high PK similarity between GB242 and its marketed reference infliximab in healthy subjects. Both treatments showed comparable safety and immunogenicity.
ChiCTR-IPR-15007098.
第一作者机构：[1]Department of Pharmacy, Peking University People’sHospital, Beijing, China[2]Department of Pharmacy Administration and ClinicalPharmacy, School of Pharmaceutical, Peking University,Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Tan,Chen Guihong,Liu Chang,et al.A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects.[J].BIODRUGS.2019,33(1):93-100.doi:10.1007/s40259-018-0326-x.
APA：
Zhang Tan,Chen Guihong,Liu Chang,Zu Li'an,Wang Qi...&Fang Yi.(2019).A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects..BIODRUGS,33,(1)
MLA：
Zhang Tan,et al."A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects.".BIODRUGS 33..1(2019):93-100
