Chalmers, James D. http://orcid.org/0000-0001-5514-7868
Usansky, Helen
Rubino, Christopher M.
Teper, Ariel
Fernandez, Carlos
Zou, Jun
Mange, Kevin C.
Funding for this research was provided by:
Insmed Incorporated
Article History
Accepted: 26 May 2022
First Online: 25 July 2022
Declarations
:
: The phase I study, phase II WILLOW study, and PK/PD analysis presented in this publication were funded by Insmed Incorporated, Bridgewater, NJ, USA. The Open Access fee for the published article also was supported by Insmed Incorporated.
: Institute for Clinical Pharmacodynamics (ICPD), Inc. received funding from Insmed Incorporated to conduct the analyses and provide general consulting to Insmed Incorporated. Helen Usansky, Carlos Fernandez, Ariel Teper, Jun Zou, and Kevin C. Mange are employees of and shareholders in Insmed Incorporated. Christopher M. Rubino is an employee of ICPD, Inc. James D. Chalmers has received grants and personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Zambon, and Insmed Incorporated; a grant from Gilead; and personal fees from Novartis and Chiesi.
: Individual anonymized participant data will not be made available.
: Both the phase I and WILLOW studies were performed in accordance with the ethical principles of the Declaration of Helsinki, the Good Clinical Practice guidelines of the International Council for Harmonisation, and applicable regulatory requirements.
: All study participants provided written informed consent prior to any study procedures.
: All authors approved and provided consent for publication.
: All authors contributed to study conception, data visualization, and the review and editing of the manuscript. JDC conducted research investigations. HU and CMR curated and analyzed data, conducted research investigations, developed methods, administered projects, supplied resources, developed and programmed software, supervised research activities, validated experiments, and wrote the original draft of the manuscript. AT and CF analyzed data, developed methods, and administered projects. JZ analyzed data, developed methods, developed and programmed software, and validated experiments. KCM analyzed data, developed methods, and supervised research activities.
: Not applicable.