Exploratory IND studies usually involve very limited human exposure and have no therapeutic or diagnostic intent, but such studies can serve a number of useful goals, such as:
- Determining whether a mechanism of action defined in experimental systems can also be observed in humans (e.g. a binding property or inhibition of an enzyme)
- Providing important information on pharmacokinetics (PK)
- Selecting the most promising lead product from a group of candidates designed to interact with a particular therapeutic target in humans, based on PK or pharmacodynamic (PD) properties
- Exploring a product’s biodistribution characteristics using various imaging technologies
Because exploratory IND studies present fewer potential risks than do traditional phase 1 studies that look for dose-limiting toxicities, such limited exploratory IND investigations in humans can be initiated with less, or different, preclinical support than is required for traditional IND studies.
