The Karolinska Trial Alliance (KTA) Phase I Unit conducts clinical trials for the pharmaceutical/medical appliance industry and for academic researchers. <?xml:namespace prefix = o />

Small, medium and large drug companies from across Europe, India, Japan or the US, contact KTA directly or through a contract research organization or sometimes through physicians of the Karolinska University Hospital (located at Huddinge and Solna).

The Phase I Unit is based at the Karolinska University Hospital, Huddinge/Stockholm and is an integrated part of the Hospital which in its turn is part of the Stockholm County Council (Stockholms läns landsting).

Our cooperation with the various departments of the Hospital and with the Karolinska Institute give us access to the extensive resources of one of Europe´s leading university hospitals including its specialty clinics, intensive care unit, radiology department and laboratory, as well as the Karolinska Institute’s world-leading researchers. Besides, all the equipment of the KTA Phase I unit are continuously controlled by the Hospital's medical technician department.

The Phase I Unit has 16 beds (10 telemetry beds) and experienced GCP-trained personnel to carry out clinical studies from first-time-in-man to proof of concept. Our primary staffing includes a unit manager, two full time specialist physicians, two intensive care unit nurses and a biomedical technician. Additional physicians and nurses are employed through a large staffing pool.

Our core competencies includes first-in-man administration of investigational products including vaccines (SAD, MAD, integrated protocols and food interaction), proof of concept studies, imaging studies (PET, PET-CT and fMRI), bioequivalence/bioavailability studies, urine catheterization studies, glycemic clamp studies and biopsy studies. Six to seven clinical trials are run at the unit per year.

Through our own electronic database with over 8000 registered healthy volunteers and a growing number of patients as well as access to the Hospital’s network of clinics, we have available a broad range of patient populations. Since 2003, our clinical studies have included patients with heart disease, CNS diseases(Alzheimer´s, Parkinson´s and multiple sclerosis), diabetes mellitus type 1 and 2 and other endocrine diseases, autoimmune diseases including inflammatory bowel disease( Crohn´s disease and ulcerative colitis), pollen allergy, and obesity in addition to elderly patients and postmenopausal females.

The KTA database is categorized according to age, gender, smoking habits etc so that researchers may easily find the right profile. However, it might not be that easy to recruit patients with certain diseases which might necessitate looking for such patients from all over Sweden.

The KTA Phase I unit at the Karolinska University Hospital fulfils the GCP (good clinical practice) standards for a Phase I unit and all other guidelines for first-in-man studies. The unit was last inspected by the Swedish Medical Products Agency on the 18th of Jan 2010.

Nabil Al-Tawil,

Medical Director 

MD, MSc, PhD, Consultant                                          

Specialist physician, Principal Investigator        
Telephone: +46 8 585858 84 
Mobile: +46 701621045
Fax: +46 8 5858 6920