Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study
ABSTRACT Allergic asthma, characterized by airborne allergen sensitivity and Th2 immune responses, is a common and increasing global health concern. Omalizumab, while effective, has limitations such as weight‐ and IgE‐dependent dosing regimens. JYB1904, a recombinant anti‐IgE humanized monoclonal an...
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Wiley
2025-06-01
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| Series: | Clinical and Translational Science |
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| Online Access: | https://doi.org/10.1111/cts.70264 |
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| author | Zhen‐Wei Shen Ting‐Han Jin Kai‐Qi Wu Jie Zhao Qi Jiang Tong Guo Liang Li Xiao‐Hua Feng Pei‐pei Liu Gui‐Ling Chen |
| author_facet | Zhen‐Wei Shen Ting‐Han Jin Kai‐Qi Wu Jie Zhao Qi Jiang Tong Guo Liang Li Xiao‐Hua Feng Pei‐pei Liu Gui‐Ling Chen |
| author_sort | Zhen‐Wei Shen |
| collection | DOAJ |
| description | ABSTRACT Allergic asthma, characterized by airborne allergen sensitivity and Th2 immune responses, is a common and increasing global health concern. Omalizumab, while effective, has limitations such as weight‐ and IgE‐dependent dosing regimens. JYB1904, a recombinant anti‐IgE humanized monoclonal antibody (IgG1 subtype), showed superior preclinical properties. We performed a single‐center, randomized, double‐blind, placebo‐controlled, single ascending‐dose phase Ia trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of JYB1904 in healthy adult participants across five dose levels (range: 75–600 mg; subcutaneously). JYB1904 was well tolerated, with no serious adverse events or safety concerns beyond those observed with omalizumab. Immunogenicity risk was low. PK analysis revealed approximately dose‐proportional parameters and an extended half‐life (2.5 times that of omalizumab). PD results showed significant free IgE suppression, with JYB1904 demonstrating stronger activity than omalizumab at equivalent doses. JYB1904 offers promising clinical advantages over omalizumab, including extended dosing intervals and enhanced efficacy, warranting further investigation for allergic asthma treatment. |
| format | Article |
| id | doaj-art-acb2af6645c84bd7aa40afa1ffa93b13 |
| institution | Matheson Library |
| issn | 1752-8054 1752-8062 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj-art-acb2af6645c84bd7aa40afa1ffa93b132025-06-26T13:31:17ZengWileyClinical and Translational Science1752-80541752-80622025-06-01186n/an/a10.1111/cts.70264Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled StudyZhen‐Wei Shen0Ting‐Han Jin1Kai‐Qi Wu2Jie Zhao3Qi Jiang4Tong Guo5Liang Li6Xiao‐Hua Feng7Pei‐pei Liu8Gui‐Ling Chen9Department of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaDepartment of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaDepartment of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaDepartment of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaDepartment of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaDepartment of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaShanghai Jemincare Pharmaceutical co., Ltd. Shanghai P. R. ChinaShanghai Jemincare Pharmaceutical co., Ltd. Shanghai P. R. ChinaShanghai Jemincare Pharmaceutical co., Ltd. Shanghai P. R. ChinaDepartment of Phase 1 Clinical Research Center Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University Hangzhou P. R. ChinaABSTRACT Allergic asthma, characterized by airborne allergen sensitivity and Th2 immune responses, is a common and increasing global health concern. Omalizumab, while effective, has limitations such as weight‐ and IgE‐dependent dosing regimens. JYB1904, a recombinant anti‐IgE humanized monoclonal antibody (IgG1 subtype), showed superior preclinical properties. We performed a single‐center, randomized, double‐blind, placebo‐controlled, single ascending‐dose phase Ia trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of JYB1904 in healthy adult participants across five dose levels (range: 75–600 mg; subcutaneously). JYB1904 was well tolerated, with no serious adverse events or safety concerns beyond those observed with omalizumab. Immunogenicity risk was low. PK analysis revealed approximately dose‐proportional parameters and an extended half‐life (2.5 times that of omalizumab). PD results showed significant free IgE suppression, with JYB1904 demonstrating stronger activity than omalizumab at equivalent doses. JYB1904 offers promising clinical advantages over omalizumab, including extended dosing intervals and enhanced efficacy, warranting further investigation for allergic asthma treatment.https://doi.org/10.1111/cts.70264allergic asthmafree IgE suppressionJYB1904pharmacodynamicspharmacokineticsphase Ia trial |
| spellingShingle | Zhen‐Wei Shen Ting‐Han Jin Kai‐Qi Wu Jie Zhao Qi Jiang Tong Guo Liang Li Xiao‐Hua Feng Pei‐pei Liu Gui‐Ling Chen Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study Clinical and Translational Science allergic asthma free IgE suppression JYB1904 pharmacodynamics pharmacokinetics phase Ia trial |
| title | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study |
| title_full | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study |
| title_fullStr | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study |
| title_full_unstemmed | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study |
| title_short | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single‐Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double‐Blind, Placebo‐Controlled Study |
| title_sort | safety tolerability pharmacokinetics pharmacodynamics and immunogenicity profiles of a single dose jyb1904 in healthy chinese participants a phase ia randomized double blind placebo controlled study |
| topic | allergic asthma free IgE suppression JYB1904 pharmacodynamics pharmacokinetics phase Ia trial |
| url | https://doi.org/10.1111/cts.70264 |
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