Phase I Unit

KTA Phase I conducts clinical studies for the pharmaceutical- and Medtech industry as well as for academic researchers. The unit is located at Karolinska University hospital in Huddinge.

KTA collaborates with various departments of Karolinska University Hospital and with the Karolinska Institute which gives access to the extensive resources including specialty clinics, intensive care unit, radiology department, and laboratory, as well as world-leading researchers.

KTA Phase I Unit has 16 beds and experienced GCP-trained personnel to carry out clinical studies from first-time-in-man to proof of concept. Our core competences include first-in-man administration of investigational products, bioequivalence/bioavailability studies, biopsy studies, healthy volunteer studies as well as patient studies.

Site facilities

  • 950 m2
  • 16 hospital beds
  • Flexibility to maximize space utilization
  • Appropriate patient monitoring
  • Blood pressure registration
  • Digital ECG monitoring
  • Continuous Holter monitors
  • Continuous cardiac monitoring and telemetry
  • On site lab processing
  • Electronic medical records
  • Emergency room
  • Intensive care unit within hospital service.
  • Drug refrigerator and freezers with alarm system
  • Freezers (-20°C, -70°C)
  • High quality custom-made analyses referrals for each study

Therapeutic areas

  • Cardiovascular
  • Central nervous system
  • Metabolic
  • Respiratory & inflammation
  • Urology & gastroenterology
  • Vaccines & infectious diseases

Extensive Track Record and Dedicated Staff

  • Micro-dosing studies
  • Imaging studies with PET, PET/CT and MRI
  • CLAMP studies for insulin sensitivity
  • Food & drug interactions studies
  • Pharmacokinetic/Pharmacodynamic studies
  • First in Man Administration (single & multiple)
  • Bioavailability studies
  • Medical Device
  • Patient studies

Close Collaborations Within  Karolinska University Hospital

  • Laboratories
  • Pharmacies
  • Nuclear medicine
  • PET- center
  • MR-center
  • X-ray department
  • Emergency and intensive care unit
  • Easy access to / well developed collaboration with medical  specialists

Recruitment of Patients and Healthy Volunteers

  • Database with 15 000 subjects listed
  • Easy selection and pre-screening
  • Efficient screening procedures
  • Collaborations with specialist clinics and GPs for recruitment

Quality Assurance

  • QA systems, SOPs
  • Complete descriptions of working procedures
  • Regular audits
  • Equipment continuously controlled and calibrated covering safety and function
  • Inspected by Swedish Medical  Products Agency (MPA)
  • inspected for First in Man, FDA