Traditional approaches to First-In-Human (FIH) trials typically involve a Single Ascending Dose (SAD) phase, followed by a Multiple Ascending Dose (MAD) phase, with a Food Effect component initiated thereafter. To reduce Phase I clinical timelines by up to 67%, Algorithme Pharma uses an Adaptive Integrated Design which overlaps the SAD, MAD and Food Effect phases and allows for the possibility of incorporating a Proof-of-Concept (POC) arm in patients.
The Integrated Design also provides the benefit of investigating new dose levels in adaptive cohorts based on real-time results. To ensure participant safety, the start-stop criteria are developed and implemented prior to trial commencement. With the Adaptive Integrated Design, both the SAD and MAD phases are completed simultaneously allowing for accelerated clinical results and an earlier entry into Phase II.
Click here to view our Poster Podcast, Case Study Comparison: The Adaptive Integrated Design vs the Traditional Sequential Approach which was presented at the 2013 CSPS & CRS Annual Symposium.