On 13 March 2006 eight healthy male volunteers entered the first phase of a 'first-in-man' study, TGN1412-HV, designed to test the safety of TGN1412, a monoclonal antibody produced by the company TeGenero. This chapter focuses on the TGN1412-HV trial, which is a useful one to use to make many points of relevance to first-in-man studies generally. The chapter highlights that careful planning is necessary for first-in-man studies and that planning is not possible without calculation. In TGN1412-HV subjects were not dosed simultaneously but at intervals of 10 minutes according to the schedule. The chapter discusses the issues that could be addressed in constructing a design and also in making statements about eventual analysis. The general message of the chapter is that careful planning is necessary for first-in-man studies and that planning is not possible without calculation.
|Title of host publication||Statistical Methods for Evaluating Safety in Medical Product Development|
|Number of pages||15|
|Publication status||Published - 23 Feb 2015|
- First-in-man trials
- Healthy volunteers
- Trial design