Gao, Lan https://orcid.org/0000-0002-2528-7656
Kaushik, Diksha
Ingalls, Kimberly
Milner, Sarah
Smith, Neil
Kong, Ronald
Funding for this research was provided by:
PTC Therapeutics
Article History
Accepted: 23 August 2024
First Online: 24 September 2024
Declarations
:
: This study was funded by PTC Therapeutics, Inc.
: All authors are employees of PTC Therapeutics Inc. and may own stocks in the company.
: This phase I study was conducted at a single clinical research facility (Baltimore, MD, USA) in full compliance with the protocol and the principles of the International Council for Harmonization Good Clinical Practice, the Declaration of Helsinki, and applicable US Food and Drug Administration regulatory requirements. The study protocol was approved by an independent ethics committee (Advarra Institutional Review Board, Columbia, MD, USA) prior to initiation and was conducted using Parexel International (Baltimore, MD, USA).
: All subjects provided written informed consent prior to entering the study.
: Not applicable.
: All data supporting the findings of this study are available within the article.
: Not applicable.
: LG: conceptualization, design, and analysis; DK: sample analysis; KI: medical monitoring; SM: design; NS: supervision; and RK: supervision. All authors contributed to the writing of the manuscript.