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Authors
Zhang, Xin https://orcid.org/0000-0002-4064-6805
Otani, Yuki https://orcid.org/0000-0002-7184-8776
Payne, Christopher D. https://orcid.org/0000-0003-0549-5455
Morris, Nathan J. https://orcid.org/0000-0001-7989-5764
Chua, Laiyi https://orcid.org/0009-0003-5417-3062
Escobar, Rodrigo
Wang, Sihe
Shi, Galen
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04607733 at ClinicalTrials.govnct05069896 at ClinicalTrials.govDocuments that mention this clinical trial
Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants
https://doi.org/10.1007/s12325-025-03335-z
Documents that mention this clinical trial
Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants
https://doi.org/10.1007/s12325-025-03335-z
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Funding
Funding for this research was provided by:
Eli Lilly and Company
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Article History
Received: 13 June 2025
Accepted: 29 July 2025
First Online: 3 September 2025
Declarations
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: Xin Zhang, Yuki Otani, Christopher D. Payne, Nathan J. Morris, Laiyi Chua, Rodrigo Escobar, Sihe Wang, and Galen Shi are employees and shareholders of Eli Lilly and Company.
: Both studies were conducted in accordance with the study protocols and with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, International Council for Harmonisation Good Clinical Practice Guidelines, and applicable laws and regulations. The study protocols were approved by the institutional review boards at each study site. All participants entered into the study provided written informed consent. Ethical review boards were in place for both studies: the WCG Independent Review Board was the overall (“master”) ethics committee for Study AMBW, and the Salus Institutional Review Board was the overall (“master”) ethics committee for Study AMBX. Informed consent forms, required to provide details about why the research was being done and what it would involve, were approved by the respective review boards and provided to participants. Subsequent dated written informed consent was required by each participant before the participant could participate in the study. The informed consent forms also noted that study data which did not directly identify participants could be published.
