Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

We are an academia-affiliated clinical research center with 25+ years of experience in early-phase and proof-of-concept clinical trials.

© Fraunhofer ITEM

Clinical Trials

Early-Phase and Proof-of-Concept Studies

State-of-the-art clinical research infrastructure
The Clinical Research Center Hannover (CRC Hannover) offers modern outpatient and inpatient facilities, including a dedicated Phase I unit, a bronchoscopy suite, advanced imaging capabilities, a biobank, and a comprehensive biomarker laboratory. Our research department operates five challenge rooms, including the Fraunhofer Allergen Challenge Chambers for controlled exposure to natural pollen (grass and birch), house dust allergens, ozone, and hypoxia.

Scientific and technological expertise
Our capabilities include well-established human challenge models (allergen, LPS/endotoxin, and ozone), bronchoscopy-based studies, and advanced MRI techniques, including hyperpolarized xenon imaging. We also provide direct access to human biospecimens such as bronchoalveolar lavage (BAL), induced sputum, and exhaled particles. Advanced immunology and biomarker analyses are available through flow cytometry, chip cytometry, and ultrasensitive multiplex platforms.

Efficient study planning and recruitment
A large database of well-characterized patients and healthy volunteers, supported by an experienced recruitment team, enables predictable timelines and high-quality study delivery.

Our Services in Early-phase Clinical Trials (First in Human to Phase II)

View into a pollen exposure chamber with test subjects, monitored by medical staff behind a glass panel.
© Fraunhofer ITEM
  • Scientific consulting and strategic study planning
  • Selection of optimal proof-of-concept models and tailored study designs
  • Seamless execution of your clinical trials from First-in-Human through Phase II
  • Bronchoscopy studies and bronchoscopic sampling (BAL, brushings, bronchosorption)
  • Lung pharmacokinetics including bronchosorption and analysis of exhaled particles
  • Inhaled and segmental challenge models with LPS (endotoxin), allergens, and methacholine
  • Imaging studies (MRI, HRCT, CT) including hyperpolarized xenon MRI
  • Biomarker discovery and comprehensive biomarker analytics

Our Clinical Research Methods and Technologies

Phase I Studies

  • Adaptive trial designs
  • Combined healthy volunteer and patient studies
  • Pharmacodynamic endpoints (biomarkers, imaging, etc.)
  • Pulmonary pharmacokinetics

Biomarker Analytics

  • Sputum Core Facility
  • Sample processing and analysis, Multiplex assay platforms (MSD, Luminex)
  • Advanced immune and tissue analytics e.g. spatial transcriptomics and proteomics (CosMx)
 

© Fraunhofer ITEM, Felix Schmitt

Deep dive into our technologies and methods?

Imaging in Clinical Trials

  • Functional lung MRI (proton based), including Phase-Resolved Functional Lung MRI (PREFUL)
  • Gas-enhanced MRI  (¹²⁹Xe, ¹⁹F)
  • Photon-counting CT

Bronchoscopy and Challenge Studies

  • Inhaled and segmental LPS (endotoxin) and allergen challenge models
  • Allergen Challenge Chamber studies
  • Bronchosorption techniques

Our Investigators

Our clinical investigators, Prof. Dr. Jens Hohlfeld, Prof. Dr. Antje Prasse, and Dr. Philipp Badorrek, combine extensive clinical expertise with a strong scientific track record.

As authors and co-authors of numerous peer-reviewed publications, they provide tailored guidance and support throughout all stages of your clinical research projects.

Prof. Jens Hohlfeld

Prof. Jens Hohlfeld is a pulmonologist and allergist, and a leading expert in early-phase clinical research in respiratory medicine. He serves as Director of the Clinical Research Division at Fraunhofer ITEM and as Full Professor of Airway Research and Aerosol Medicine at Hannover Medical School.

He has developed several clinical challenge models using environmental allergens, endotoxin, rhinovirus, and ozone for proof-of-concept studies, along with innovative methods to monitor pulmonary pharmacokinetics and airway inflammation.

Prof. Hohlfeld is a member of the American Thoracic Society (ATS), the European Respiratory Society (ERS), the International Society for Aerosols in Medicine (ISAM), and the German Respiratory Society. He also serves as a reviewer for the German Research Foundation and for several international scientific journals.

He has authored or co-authored more than 230 scientific publications.

Prof. Antje Prasse

Prof. Dr. Antje Prasse is a pulmonologist and a leading expert in interstitial lung diseases (ILD). She heads the Department of Clinical and Translational Fibrosis Research at Fraunhofer ITEM. She previously led the ILD Center at the University Medical Center Freiburg for seven years and later established a clinical ILD center at Hannover Medical School. The center currently follows more than 500 patients with ILD, including over 100 with idiopathic pulmonary fibrosis (IPF).

With a strong track record in personalized medicine and biomarker research, she served as a Visiting Professor at Yale University from 2013 to 2014 (host: Prof. Naftali Kaminski). Prof. Prasse has extensive experience in multi-omics technologies and has developed both in vitro disease models and a humanized mouse model of IPF.

In 2015, she received the European Respiratory Society Research Award for Idiopathic Pulmonary Fibrosis.

Dr. Philipp Badorrek

Dr. Badorrek is a board-certified clinical pharmacologist and principal investigator with extensive experience in clinical research and a proven track record of leading a clinical operations department of more than 30 professionals. He oversees all phases of clinical studies, both scientific and operational, ensuring compliance with regulatory requirements and ethical standards while proactively addressing recruitment challenges.

He is highly skilled in mentoring teams, fostering cross-functional collaboration, and delivering high-quality outcomes through efficient study execution and rigorous quality standards, with a strong focus on client satisfaction and overall study success.