OF 02.003

"Clinical Trial Unit (CTU)"

Haefeli Walter E.

University Hospital Heidelberg

Medical Clinic, Department of Clinical Pharmacology and Pharmacoepidemiology

In Neuenheimer Feld 410

69120 Heidelberg, Germany

Phone: 0049-6221-56 8740

Email: walter-emil.haefeli@med.uni-heidelberg.de

Curriculum vitae

INTERNAL

Project Specific Informations

Short Summary

As an Early Clinical Trial Unit at Heidelberg University Hospital, the Clinical Pharmacology Study Center (KliPS) primarily conducts early-phase drug trials (Phase 0, 1) in patients and healthy volunteers, but is also involved in Phase II and, less frequently, Phase III studies. The early trials include, in particular, first-in-human (FIH) studies, such as for the peptide Myrcludex B (bulevirtide) developed at DZIF or a malaria vaccine from the Heidelberg Campus directed against the surface antigen MSP-1. In addition, Phase I trials on safety aspects are also performed, such as drug-drug interaction studies (e.g., bulevirtide: PMID: 28543042), studies in elimination disorders (e.g., voriconazole: PMID: 20368400), or drug-food interaction studies (e.g., tacrolimus, PMID: 33641238). Another special feature is the local mass spectrometry park, which is regularly used for the analysis of antimicrobial substances, such as myrcludex B (PMID: 34018034), HIV antivirals (PMID 17161668, 17639576), or antibiotics (PMID 31279892). In addition, ultrasensitive methods are being developed to perform interaction studies without side effects with micro dosing (e.g., PMID 23511711).

Highlights

    seven FIM trials using antimicrobial agents conducted by KliPSNone
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