Phase-0 Microdosing Studies
Phase 0 studies, so named because they are positioned between pre-clinical and phase I stages, have the potential to improve pre-clinical candidate selection by providing human in vivo data earlier in the development process than with traditional approaches.
Phase 0 studies support the performance of first-in-human testing of new investigational agents at sub-therapeutic doses (100 μg or less) based on reduced manufacturing and toxicologic requirements, allowing the demonstration of drug-target effects and assessment of PK-PD relationships in humans earlier in clinical development.
The Micro study is a small, exploratory Phase 0 experimental medicine study seeking to test the hypotheses that ADS032 can attenuate components of the immune system (alveolar macrophages) when delivered at microdose concentrations.
This study will specifically address whether ADS032 when delivered in situ in the distal human inflamed lung is active in the target cell of interest in a relevant patient population. We will explore this in suspected or confirmed ILD patients and in bronchiectasis patients and also in patients who are having planned lung resections. This study will commence in the summer of 2023 in NHS Lothian and is predicted to take 6 months to complete.
We are also currently setting up a microdosing platform where we will be able to dose multiple agents in the lung at the same time.
