Sechaud, Romain
Gu, Helen
Rahmanzadeh, Gholamreza
Chiparus, Ovidiu
Breitschaft, Astrid
Menssen, Hans D.
Funding for this research was provided by:
Novartis
Article History
Received: 2 February 2024
Accepted: 12 June 2024
First Online: 7 August 2024
Declarations
:
: R Sechaud, G Rahmanzadeh, and H Menssen are employees of Novartis Pharma AG, Switzerland. H Gu and O Chiparus, are employees of Novartis Pharmaceuticals Corporation, USA. A Breitschaft is an employee of Parexel International GmbH, Germany.
: The study was performed in accordance with the ethical principles, which have their origin in the Declaration of Helsinki and are consistent with Good Clinical Practice and applicable regulatory requirements. All participants of the study provided written informed consent according to international standards. The study conducted at the Early Phase Clinical Unit of PAREXEL International GmbH in Berlin, Germany. The study protocol was reviewed and approved by the State Office of Health and Social Affairs Ethics Committee of Berlin (Landesamt für Gesundheit und Soziales Ethik-Kommission des Landes Berlin) for PAREXEL International GmbH. The A2121 study was registered under EudraCT number: EudraCT number: 2018-000971-34, and it obtained a favorable opinion from the IEC. The study participants were informed about the study procedures, risks, and benefits of their participation. Informed consent was documented by the investigator.