Janssen CPU, state-of-the-art center for phase 1 clinical trials in Belgium
The Janssen Clinical Pharmacology Unit (CPU) is a state-of-the-art clinical trial center in Belgium focused on phase 1 clinical trials, in line with Belgium’s remarkable European and global position in high-quality early phase clinical research. The Clinical Pharmacology Unit is located at the Jan Palfijn Hospital in Merksem. It is here that many of Janssen’s drug candidates are administered to humans for the first time.
New medicines have a long way to go before they effectively reach the patient. After years of laboratory research, the safety and efficacy of new drug candidates are evaluated in humans in clinical trials. Typically, new drug candidates go through three phases of clinical research to demonstrate that they are safe and effective. This includes studies in both healthy volunteers and - in some cases - patients (phase 1), small groups of patients (phase 2) and large groups of patients (phase 3). Only after all studies have been conducted, regulatory authorities will be able to approve the drug candidate as a new medicine.
Smaller groups of healthy volunteers and patients
Phase 1 clinical trials at the Clinical Pharmacology Unit test new drug candidates in healthy volunteers and/or patients in order to investigate their safety and how well they are tolerated, absorbed and broken down by the human body. These studies typically consist of 20-100 healthy volunteers and/or patients. The data obtained from these studies can be used to select the dose for later phase 2 studies, which are aimed at providing evidence of a treatment benefit in a larger group of patients.
Years of experience in phase 1 clinical trials
Janssen has been investing for years in leading clinical studies in Belgium. In 2000, all of Janssen's Phase 1 units worldwide were merged into the Jan Palfijn Hospital, which has since become a center of knowledge and expertise for Phase 1 clinical trials. The CPU is able to handle the most complicated and innovative study designs.
The CPU uses state-of-the-art technology and applies strict ethical standards in conducting early-phase clinical trials. The safety of the participants, as well as the quality of the data, is central to the conduct of all clinical trials. The CPU meets the strictest standards in this regard. With the support of volunteers and patients, we are committed to truly understanding the potential of new medicines, and to deliver innovative, high-quality clinical data for the future of patient care.