Tomoko Hasunuma, Clive Grattan, Takashi Eto, Michio Yagi, Rie Yazawa, Sunghyun Kim, Yunju Bae, Suyoung Kim, Jeong Eun Park, Jongho Kim, Sarbjit Saini
{"title":"CT - P39通过自动注射器的药代动力学和安全性与通过预填充注射器的参考omalizumab相当。","authors":"Tomoko Hasunuma, Clive Grattan, Takashi Eto, Michio Yagi, Rie Yazawa, Sunghyun Kim, Yunju Bae, Suyoung Kim, Jeong Eun Park, Jongho Kim, Sarbjit Saini","doi":"10.1080/1750743X.2025.2467026","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>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.</p><p><strong>Participants & methods: </strong>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<sub>0-inf</sub>) and maximum serum concentration (C<sub>max</sub>). 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.</p><p><strong>Results: </strong>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<sub>0-inf</sub> (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and C<sub>max</sub> (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.</p><p><strong>Conclusions: </strong>CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"113-121"},"PeriodicalIF":2.7000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901399/pdf/","citationCount":"0","resultStr":"{\"title\":\"Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe.\",\"authors\":\"Tomoko Hasunuma, Clive Grattan, Takashi Eto, Michio Yagi, Rie Yazawa, Sunghyun Kim, Yunju Bae, Suyoung Kim, Jeong Eun Park, Jongho Kim, Sarbjit Saini\",\"doi\":\"10.1080/1750743X.2025.2467026\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>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.</p><p><strong>Participants & methods: </strong>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<sub>0-inf</sub>) and maximum serum concentration (C<sub>max</sub>). 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.</p><p><strong>Results: </strong>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<sub>0-inf</sub> (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and C<sub>max</sub> (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.</p><p><strong>Conclusions: </strong>CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.</p>\",\"PeriodicalId\":13328,\"journal\":{\"name\":\"Immunotherapy\",\"volume\":\" \",\"pages\":\"113-121\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901399/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Immunotherapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/1750743X.2025.2467026\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/28 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Immunotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/1750743X.2025.2467026","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/28 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe.
Aims: 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 (AUC0-inf) and maximum serum concentration (Cmax). 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.
Results: 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 AUC0-inf (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and Cmax (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.
Conclusions: CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.
期刊介绍：
Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field.
Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.
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