Issue 18: Planning Your First-In-Human Trial

A first-in-human clinical trial is a significant milestone in the development of a potential new drug in that it will be the first opportunity for a drug development sponsor to evaluate the impact of their new chemical entity or biologic in humans. Typically, first-in-human trials with compounds intended for treatment of diseases other than cancers or certain rare non-malignant diseases are conducted using healthy normal volunteers, unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.