MATERIALS AND METHODS
SAD
LUNG
The phase I single ascending dose (SAD) and food effects study was conducted at one site in Toronto, Canada (INC Research Toronto, Inc.), and the phase I/IIa multiple ascending dose/early bactericidal activity (MAD/EBA) study (ClinicalTrial.gov identifier: NCT03678688) was conducted at two sites in South Africa (University of Cape Town Lung Institute [Pty.] Ltd., Cape Town, South Africa and TASK Clinical Research Centre, Cape Town, South Africa). Both trials were sponsored by Otsuka America Pharmaceutical Development & Commercialization, Inc. (Rockville, MD, USA) and complied with International Conference on Harmonization and Good Clinical Practice guidelines for conducting, recording, and reporting clinical trials and for archiving essential documents, as well as with current regulatory and ethical guidelines at the study sites. Written consent was obtained from each participant. The informed consent form, protocol and amendments for the study were approved by the institutional review board or independent ethics committee at each trial site.