Joseph, David
Thoma, Christian
Haeufel, Thomas
Li, Xiujiang
Clinical trials referenced in this document:
Documents that mention this clinical trial
Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies
https://doi.org/10.1007/s40262-022-01176-5
Documents that mention this clinical trial
Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies
https://doi.org/10.1007/s40262-022-01176-5
Documents that mention this clinical trial
Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies
https://doi.org/10.1007/s40262-022-01176-5
Documents that mention this clinical trial
Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies
https://doi.org/10.1007/s40262-022-01176-5
Documents that mention this clinical trial
Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies
https://doi.org/10.1007/s40262-022-01176-5
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Accepted: 29 August 2022
First Online: 1 December 2022
Declarations
:
: This study was funded by Boehringer Ingelheim.
: David Joseph and Xiujiang Li are employees of Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. Christian Thoma is an employee of Boehringer Ingelheim International GmbH, Biberach, Germany. Thomas Haeufel is an employee of Boehringer Ingelheim International GmbH, Ingelheim, Germany.
: These studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation Good Clinical Practice Guidelines, and all local regulatory requirements were followed.
: All subjects were advised on the risks and benefits of participation in these studies and submitted written informed consent.
: All subjects signed informed consent regarding publication of their study data.
: To ensure independent interpretation of clinical study results and enable authors to fulfil their role and obligations under the International Committee of Medical Journal Editors criteria, Boehringer Ingelheim grants all external authors access to clinical study data pertinent to the development of the publication. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data when it becomes available on ExternalRef removed, and earliest after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Please visit ExternalRef removed for further information.
: Not applicable.
: All authors equally contributed to the concept, design and drafting of the manuscript. All authors read and approved the final manuscript. All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work as a whole and have given their approval for this version to be published.