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.