First-in-Patient Trials

The first clinical trial in patients is always a safety study in a general sense. More specifically, a dedicated safety study in patients under highly controlled conditions may be required to investigate some special objectives. In-house safety trials in patients (phase-Ib) with adequate safety monitoring procedures will be conducted at the beginning of the phase-II clinical program, if the special pathophysiology of the disease may probably be associated with an increased risk that may not be present in healthy subjects. Inamed’s clinical personnel is experienced in the conduct of such safety trials in patients, and our clinical pharmacology experts can provide scientific advice and expertise as regards content of clinical study protocols.