SOUSEIKAI Hakata Clinic, Fukuoka, 812-0025, Japan.
Nishikumamoto Hospital, Kumamoto, 861-4157, Japan.
Immunotherapy. 2023 Feb;15(3):149-161. doi: 10.2217/imt-2022-0181. Epub 2023 Feb 7.
Comparing pharmacokinetics and safety of CT-P17 and EU-approved reference adalimumab (EU-adalimumab) in Japan. Double-blind, parallel-group phase I trial at three hospitals. Healthy Japanese adults were randomized (1:1) to CT-P17 or EU-adalimumab (single 40-mg subcutaneous dose). The primary end point was pharmacokinetic equivalence for area under the concentration-time curve from time zero to infinity and maximum serum concentration. Of the 205 randomized subjects (102 CT-P17, 103 EU-adalimumab), 204 received study drug. CT-P17 and EU-adalimumab were pharmacokinetically equivalent: 90% CIs for geometric least-squares mean ratios were within predefined 80-125% equivalence margins. Secondary pharmacokinetic end points, safety and immunogenicity were similar between the groups. CT-P17 had pharmacokinetics, safety and immunogenicity comparable to EU-adalimumab in healthy Japanese adults.
比较 CT-P17 与欧盟批准的阿达木单抗（EU-adalimumab）在日本的药代动力学和安全性。在三家医院进行的双盲、平行组 I 期试验。健康的日本成年人被随机分为 CT-P17 或 EU-adalimumab（单次 40mg 皮下注射剂量）（1:1）。主要终点是从零时到无穷大的浓度-时间曲线下面积和最大血清浓度的药代动力学等效性。在 205 名随机受试者中（102 名 CT-P17，103 名 EU-adalimumab），204 名接受了研究药物。CT-P17 和 EU-adalimumab 的药代动力学等效：几何均数最小二乘比的 90%置信区间在预先设定的 80%-125%等效范围内。两组的次要药代动力学终点、安全性和免疫原性相似。CT-P17 在健康的日本成年人中的药代动力学、安全性和免疫原性与 EU-adalimumab 相当。
