About Phase I Units
Phase 1 clinical trial is the first phase in which a newly developed drug is administered to a human (first-in-humans). Phase 1 trials are designed to test the safety, side effects, maximum-tolerated dose and drug pharmacokinetic parameters. The primary goal of phase I is not yet to verify efficacy. The aim is to prove that the drug being developed cannot cause serious harm to anyone. Phase I trials most often include healthy volunteers and is a crucial phase for further clinical research. The evaluation takes place under strictly controlled conditions and in specialized phase 1 units with full medical support. These units enable early phase clinical trials in full compliance with all legislative requirements, compliance with Good Clinical Practice (ICH GCP) and international standards.