Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial
ObjectiveTo evaluate the similarity of BAT2606 and mepolizumab, including pharmacokinetic profiles, immunogenicity, and safety, in healthy Chinese men.MethodsThis randomized, double-blind, parallel three-arm, single-dose Phase I clinical study enrolled 207 subjects. All subjects enrolled in this stu...
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Frontiers Media S.A.
2025-07-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1580883/full |
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| author | Cuiyun Li Jixuan Sun Jia Xu Min Wu Xiaojiao Li Zhijie Liu Qingfeng Dong Yu Sun Yanhua Ding |
| author_facet | Cuiyun Li Jixuan Sun Jia Xu Min Wu Xiaojiao Li Zhijie Liu Qingfeng Dong Yu Sun Yanhua Ding |
| author_sort | Cuiyun Li |
| collection | DOAJ |
| description | ObjectiveTo evaluate the similarity of BAT2606 and mepolizumab, including pharmacokinetic profiles, immunogenicity, and safety, in healthy Chinese men.MethodsThis randomized, double-blind, parallel three-arm, single-dose Phase I clinical study enrolled 207 subjects. All subjects enrolled in this study were randomly assigned to receive BAT2606 or mepolizumab (European-sourced Nucala [Nucala-EU] and US-sourced Nucala [Nucala-US]) at a 1:1:1 ratio. In total, 206 subjects received a subcutaneous injection of 100 mg of one of the drugs in this study.ResultsThe mean drug concentration–time curves were similar among the three groups. The 90% confidence intervals of the geometric mean ratios of maximum concentration and area under the curve from time 0 to infinity were within 80.00%–125.00%. There were no adverse events leading to study discontinuation or death, no serious adverse events, and no local injection-site reactions. The rates of adverse events and treatment-related adverse events were comparable among the BAT2606 (78.3% and 66.7%, respectively), Nucala-US (76.5% and 64.7%, respectively), and Nucala-EU groups (82.6% and 71.0%, respectively). The majority of treatment-related adverse events were grade 1 or 2 in severity based on Common Terminology Criteria for Adverse Events version 5.0. Anti-drug antibodies (ADAs) were detected in 4 (5.8%), 10 (14.7%), and 10 subjects (14.5%) in the BAT2606, Nucala-US, and Nucala-EU groups, respectively. All subjects with a positive ADA result were negative for neutralizing antibodies.ConclusionBAT2606 injection was pharmacokinetically bioequivalent to Nucala-US and Nucala-EU in healthy Chinese men. BAT2606 was well tolerated, and its overall safety profile was similar to those of Nucala-US and Nucala-EU. BAT2606 had a numerically lower ADA incidence than Nucala-US and Nucala-EU.Clinical Trial Registrationhttps://www.clinicaltrials.gov/study/NCT05576454?term=BAT2606&rank=1. |
| format | Article |
| id | doaj-art-2e95dd272233423497f85edc5c869682 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-2e95dd272233423497f85edc5c8696822025-08-20T03:55:48ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-07-011610.3389/fphar.2025.15808831580883Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trialCuiyun Li0Jixuan Sun1Jia Xu2Min Wu3Xiaojiao Li4Zhijie Liu5Qingfeng Dong6Yu Sun7Yanhua Ding8Phase I Clinical Research Center, First Hospital of Jilin University, Changchun, Jilin, ChinaPhase I Clinical Research Center, First Hospital of Jilin University, Changchun, Jilin, ChinaPhase I Clinical Research Center, First Hospital of Jilin University, Changchun, Jilin, ChinaPhase I Clinical Research Center, First Hospital of Jilin University, Changchun, Jilin, ChinaPhase I Clinical Research Center, First Hospital of Jilin University, Changchun, Jilin, ChinaBio-Thera Solutions, Ltd., Guangzhou, Guangdong, ChinaBio-Thera Solutions, Ltd., Guangzhou, Guangdong, ChinaBio-Thera Solutions, Ltd., Guangzhou, Guangdong, ChinaPhase I Clinical Research Center, First Hospital of Jilin University, Changchun, Jilin, ChinaObjectiveTo evaluate the similarity of BAT2606 and mepolizumab, including pharmacokinetic profiles, immunogenicity, and safety, in healthy Chinese men.MethodsThis randomized, double-blind, parallel three-arm, single-dose Phase I clinical study enrolled 207 subjects. All subjects enrolled in this study were randomly assigned to receive BAT2606 or mepolizumab (European-sourced Nucala [Nucala-EU] and US-sourced Nucala [Nucala-US]) at a 1:1:1 ratio. In total, 206 subjects received a subcutaneous injection of 100 mg of one of the drugs in this study.ResultsThe mean drug concentration–time curves were similar among the three groups. The 90% confidence intervals of the geometric mean ratios of maximum concentration and area under the curve from time 0 to infinity were within 80.00%–125.00%. There were no adverse events leading to study discontinuation or death, no serious adverse events, and no local injection-site reactions. The rates of adverse events and treatment-related adverse events were comparable among the BAT2606 (78.3% and 66.7%, respectively), Nucala-US (76.5% and 64.7%, respectively), and Nucala-EU groups (82.6% and 71.0%, respectively). The majority of treatment-related adverse events were grade 1 or 2 in severity based on Common Terminology Criteria for Adverse Events version 5.0. Anti-drug antibodies (ADAs) were detected in 4 (5.8%), 10 (14.7%), and 10 subjects (14.5%) in the BAT2606, Nucala-US, and Nucala-EU groups, respectively. All subjects with a positive ADA result were negative for neutralizing antibodies.ConclusionBAT2606 injection was pharmacokinetically bioequivalent to Nucala-US and Nucala-EU in healthy Chinese men. BAT2606 was well tolerated, and its overall safety profile was similar to those of Nucala-US and Nucala-EU. BAT2606 had a numerically lower ADA incidence than Nucala-US and Nucala-EU.Clinical Trial Registrationhttps://www.clinicaltrials.gov/study/NCT05576454?term=BAT2606&rank=1.https://www.frontiersin.org/articles/10.3389/fphar.2025.1580883/fullBAT2606 injectionbiosimilarmepolizumabpharmacokineticssafetyimmunogenicity |
| spellingShingle | Cuiyun Li Jixuan Sun Jia Xu Min Wu Xiaojiao Li Zhijie Liu Qingfeng Dong Yu Sun Yanhua Ding Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial Frontiers in Pharmacology BAT2606 injection biosimilar mepolizumab pharmacokinetics safety immunogenicity |
| title | Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial |
| title_full | Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial |
| title_fullStr | Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial |
| title_full_unstemmed | Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial |
| title_short | Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial |
| title_sort | comparison of pharmacokinetic similarity immunogenicity and safety of mepolizumab and bat2606 in healthy chinese men in a double blinded randomized single dose three arm parallel group phase i trial |
| topic | BAT2606 injection biosimilar mepolizumab pharmacokinetics safety immunogenicity |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1580883/full |
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