When drafting your IND submission, you should consider including the following clinical information:
(1) Introductory statement and general investigational plan:
- Traditional IND application – describe the rationale of the clinical trial program and the proposed clinical investigation outcome.
- Exploratory IND application – discuss a circumscribed study or group of studies and plans for further development cannot be formulated without the results of these studies. Therefore, an exploratory IND application should articulate the rationale for selecting a compound and for studying them in a single trial or related trials, as this represents all that is known about the overall development plan at this stage. This section should also make it clear that the IND is intended to be withdrawn after completion of the outlined study or studies.
(2) Types of studies
- Single-dose studies – a sub-pharmacologic or pharmacologic dose is administered to a limited number of subjects (healthy volunteers or patients).
- Multiple-dose studies – can be designed with pharmacologic or pharmacodynamic endpoints. In exploratory IND studies, the duration of dosing should be limited (e.g., 7 days). For escalating dose studies done under an exploratory IND, dosing should be designed to investigate a pharmacodynamic endpoint, not to determine the limits of tolerability.