Sauter, Max
Blank, Antje
Stoll, Felicitas
Lutz, Natalie
Haefeli, Walter E.
Burhenne, Jürgen
Funding for this research was provided by:
Physician scientist program of the medical faculty of Heidelberg University
Bundesministerium für Bildung und Forschung (03VP01020)
Article History
Received: 31 January 2021
Revised: 31 March 2021
Accepted: 29 April 2021
First Online: 20 May 2021
Declarations
:
: Plasma samples were obtained from a monocentric exploratory phase I study which was carried out at the Clinical Research Unit of the Department of Clinical Pharmacology and Pharmacoepidemiology, which is certified according to EN ISO standard 9001. The trial was under the legal sponsorship of the Medical Faculty of the Heidelberg University. The trial followed the guideline of Good Clinical Practice, the ethical principles expressed in the Declaration of Helsinki, and all legal requirements for clinical trials in Germany. It was approved by the responsible Ethics Committee of the Medical Faculty of Heidelberg University (AFmo-670/2016) and the competent national authority (BfArM, EudraCT: 2017-003137-28). Prior to participation in any trial-related procedures, each participant provided written informed consent.
: Activities for bulevirtide projects at the Department of Clinical Pharmacology and Pharmacoepidemiology were in part funded by Myr GmbH.