First-in-Man (FIM) Trials

The continuous monitoring of safety parameters (e.g., pulse rate, 3-lead ECG, oxygen saturation in peripheral blood) in combination with an alarm system and storage of data is nowadays mandatory for certain studies in early clinical development, e.g., First-in-Man (FIM) trials. Inamed is always committed to the highest quality standards in clinical research, and that is why Inamed has established a modern in-house 6-bed Intensive Monitoring Unit which is part of Inamed’s in-patient ward dedicated to the conduct of clinical studies. Inamed’s Intensive Monitoring Unit comprises six measuring stations that are equipped with modern Draeger Monitors and peripheral devices which allow the monitoring and recording of all well-established, non-invasive vital parameters. In addition to the bed-site monitors, all safety information is simultaneously displayed on a central monitor by using a modern telemetric system. Alert ranges for the different safety parameters can be individually selected according to the requirements of a certain study.

FIM trials are usually conducted as single-ascending dose (SAD) trials. The individual design issues will be selected according to the special requirements of a clinical development program. Inamed’s clinical pharmacology experts can provide scientific advice and expertise as regards content of clinical study protocols and trial design issues including FIM studies and special safety studies.