Interventions with Potential to Mitigate Injection Site Reactions Following Subcutaneous Elamipretide Administration: A Phase 1, Crossover Study
Shortened Title: Interventions to Mitigate Injection Site Reactions from Elamipretide
Authors: Alana Sullivan1, Sandrin C. Bergheanu1, Laura E. Kropp1, Li Zhang 2, Benjamin McNeil2, Lisa A. Beck3, Anthony Abbruscato 1
Affiliations: 1Stealth BioTherapeutics Inc., Needham, MA, USA; 2Division of Allergy and Immunology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA;3Carol & Lowell Goldsmith Professor of Dermatology, Medicine & Pathology, University of Rochester Medical Center, Rochester, NY, USA
Corresponding author: Kropp L
Word count : <<4617/4000>> (1727 in Methods, 1303 in Discussion and Conclusions)
Acknowledgements: Writing and editing assistance, including preparation of a draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by James A. Shiffer, RPh and Jamie Dermatis, DPM (Write On Time Medical Communications, LLC, NJ). This Phase 1 study was not preregistered following guidelines in 42 Code of Federal Regulations (CFR) Part 11.
Conflicts of interest: SCB, AS, LEK, and AA are employees of Stealth BioTherapeutics (Newton, MA)
ORCID iD: 0000-0001-9050-9385
Data availability: The data that support the findings of this study are available from the corresponding author upon reasonable request. Some data may not be made available because of privacy or ethical restrictions.
Funding : The trial was funded by Stealth BioTherapeutics (Newton, MA).
Author contribution: All authors contributed equally to production of this review. All authors read and approved the final manuscript.
Ethics approval: The clinical trial was conducted in accordance with international ethics guidelines, including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, ICH GCP guidelines, and all applicable laws and regulations. The study was approved by institutional review boards, and all participants provided written informed consent. Animal studies were conducted in compliance with the US National Research Council’s Guide for the Care and Use of Laboratory Animals, the US Public Health Service’s Policy on Humane Care and Use of Laboratory Animals, and Guide for the Care and Use of Laboratory Animals.