Document is current

Article History

Received: 11 April 2025

Accepted: 22 May 2025

First Online: 8 July 2025

Declarations

:

: Beverly Knight, Brinda Tammara, Shannon Dallas, Saro Mardirosian, Jianyao Wang, Aline Laenen, Laurent Leclercq, Karen DiLoreto, Lieve Adriaenssen, Darren Moss, David Polidori, Siladitya Ray Chaudhuri, Seonghee Park, Carlo Sensenhauser, Anthony Ndifor, Siddharth Sukumaran, Tristan Baguet, Yifan Shi, Shefali Patel, Brian Geist, Stephanie A Barros, Mario Monshouwer: Employee: Johnson & Johnson; Shareholder: may own stock/stock options in Johnson & Johnson. Nishit B Modi: Employee: Protagonist Therapeutics, Inc. Anne Fourie, Raymond Patch: Former employee: Johnson & Johnson; Shareholder: may own stock/stock options in Johnson & Johnson. Chengzao Sun, Sandeep Somani: Employee: Pinnacle Medicines; Former employee: Johnson & Johnson; Shareholder: may own stock/stock options in Johnson & Johnson. Beverly Knight, Nishit B Modi, David Polidori and Anne Fourie are listed as inventors on United States patent application published as US20240254180, related to this work. Chengzao Sun, Sandeep Somani and Raymond Patch are listed as inventors on Patent Cooperation Treaty (PCT) international patent application published as WO2021/146441, related to this work.

: Rat study protocols and procedures were conducted under the United Kingdom Home Office project license number PP9376768 that controls scientific procedures on animals in the United Kingdom under the Animals (Scientific Procedures) Act 1986. The regulations conform to the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (Strasbourg, Council of Europe) and achieve the standard of care required by the United States Department of Health and Human Services’ Guide for the Care and Use of Laboratory Animals. Monkey study protocols and procedures were reviewed and approved by the Charles River (Nevada) Institutional Animal Care and Use Committee and were conducted in compliance with applicable sections of the Final Rules of the Animal Welfare Act regulations (Code of Federal Regulations, Title 9), the Public Health Service Policy on Humane Care and Use of Laboratory Animals from the Office of Laboratory Animal Welfare, the Guide for the Care and Use of Laboratory Animals from the National Research Council. The FIH study protocol was reviewed and approved by Alfred Hospital Ethics Committee (Project 613/20 HREC/69080/Alfred-2020). The Human Research Ethics Committee (HREC) gave written approval for the Phase 1 FIH study, in accordance with local regulations. The HREC was appropriately constituted and operated in accordance with the Notes for Guidance on Good Clinical Practice (GCP, CPMP/ICH/15/95), as adopted by the Australian Therapeutic Goods Administration (TGA, 2000) and the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007, updated 2018). Each subject gave informed consent at the screening visit to participate in the study and publication. This study was conducted in accordance with the principles of the current Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects), the NHMRC National Statement on Ethical Conduct in Human Research (2007, updated 2018), and Notes for Guidance on GCP (CPMP/ICH/135/95) established from the International Conference on Harmonization guidelines and adopted by the Australian TGA (2000). All study investigations were undertaken by scientifically and medically qualified persons. The relative bioavailability study protocol was reviewed and approved by FAGG (federal agency for medicines and health products in Belgium; reference number R&D/1317536). The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCPs and applicable regulatory requirements. Informed consent was gained prior to the commencement of any study procedures.