Hello Anon. Apologies for lacking direct experience in so-called exploratory INDs, but I assume you've seen the FDA Guidance Document on the topic (
https://www.fda.gov/media/72325/download), though that GD is pretty old, and perhaps have already approached FDA for a meeting. The utility of an exploratory study depends a lot on the anticipated risks for your drug as well as the indication for use, and perhaps if it is for an unmet medical need. Much, if not all of the information you may obtain should end up being useful in any further studies, which, if the drug product is essentially unchanged, would likely continue on under the same IND with the input from FDA after they see your initial data.
I'll be curious to hear from others about their experiences. Good luck.
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Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
Consultant
United States
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Original Message:
Sent: 01-Nov-2022 19:47
From: Anonymous Member
Subject: Exploratory INDs Pros and Cons
This message was posted by a user wishing to remain anonymous
Does anyone have experience with running exploratory INDs? If so, what have you found are the pros and cons. We are considering doing a microdosing study under an exploratory IND to determine human PK quickly, but we aren't sure if that would really save us time or money if it is successful and we later conduct a traditional Phase 1a study. Would it be more beneficial to just put the human PK evaluation as a cohort in our Phase 1a study? The Phase 1a study would not necessarily be run in the US.