Phase 1 clinical program planning is complicated these days with added pressure to get maximum study data and move quickly to Phase 2 or partner the clinical asset. Whatever the plan, it makes good sense to utilize study designs and processes that save time and cost while avoiding expensive delays through identification of unseen compound safety risks typically not found until the end of Phase 2 or later.
The presenters will review the following specific study components which can be highly beneficial in terms of time and cost savings when included in a Phase 1/ First-in-Man clinical studies:
- Metabolites in Safety Testing (MIST) in SAD/ MAD studies.
- Concentration QT modeling (cQT modeling) in SAD studies.
- Time and cost-effective Dose Selection strategy for SAD studies, bridging preclinical data to First-in-Man and beyond.
An insightful overview for anyone new to Phase 1 clinical study operations and useful information for those who have not run an early clinical program in some time.