Hasunuma Tomoko, Grattan Clive, Eto Takashi, Yagi Michio, Yazawa Rie, Kim Sunghyun, Bae Yunju, Kim Suyoung, Park Jeong Eun, Kim Jongho, Saini Sarbjit
Department of Research, Clinical Trial Center, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
St John's Institute of Dermatology, Guy's Hospital, London, UK.
Immunotherapy. 2025 Feb;17(2):113-121. doi: 10.1080/1750743X.2025.2467026. Epub 2025 Feb 28.
To demonstrate pharmacokinetic equivalence of CT‑P39 administered via auto-injector (CT‑P39 AI) and European Union-approved reference omalizumab via pre-filled syringe (EU-OMA PFS) in healthy Japanese adults.
PARTICIPANTS & METHODS: This open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT‑P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration-time curve from time zero to infinity (AUC) and maximum serum concentration (C). Equivalence was concluded if the 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were contained within the predefined 80-125% equivalence margin. Secondary endpoints comprised additional pharmacokinetics, pharmacodynamics, safety, and immunogenicity.
Overall, 65 and 64 individuals were randomized to CT‑P39 AI and EU-OMA PFS, respectively. Pharmacokinetic equivalence between CT‑P39 AI and EU-OMA PFS was demonstrated for both AUC (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and C (93.91 [87.20-101.14]). Thirty-nine (60.0%; CT‑P39 AI) and 32 (50.8%; EU-OMA PFS) participants experienced treatment-emergent adverse events (TEAEs) with no serious TEAEs. Secondary endpoints were comparable between groups.
CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.
在健康日本成年人中证明通过自动注射器给药的CT-P39（CT-P39 AI）与欧盟批准的通过预填充注射器给药的对照奥马珠单抗（欧盟-奥马珠单抗PFS）的药代动力学等效性。
这项开放标签的1期研究将参与者按1:1随机分为单剂量150mg/mL的CT-P39 AI或欧盟-奥马珠单抗PFS组。主要终点是从零时间到无穷大的浓度-时间曲线下面积（AUC）和最大血清浓度（C）的药代动力学等效性。如果几何最小二乘均值（gLSMs）比值的90%置信区间（CIs）包含在预先定义的80%-125%等效范围内，则得出等效性结论。次要终点包括其他药代动力学、药效学、安全性和免疫原性。
总体而言，分别有65人和64人被随机分配至CT-P39 AI组和欧盟-奥马珠单抗PFS组。CT-P39 AI与欧盟-奥马珠单抗PFS在AUC（gLSMs比值[90%CI]为101.66[95.31-108.45]）和C（93.91[87.20-101.14]）方面均显示药代动力学等效。39名（60.0%；CT-P39 AI）和32名（50.8%；欧盟-奥马珠单抗PFS）参与者出现治疗期间出现的不良事件（TEAEs），无严重TEAEs。两组间次要终点具有可比性。
在健康日本个体中，单剂量给药后CT-P39 AI与欧盟-奥马珠单抗PFS在药代动力学上等效；药效学、安全性和免疫原性具有可比性。
