R&D
Testing one
breath at a time
The client’s
roadblock
Our client had developed a new chemical entity that needed to be delivered directly to the lungs.
To demonstrate safety, early clinical studies including single ascending dose and multiple ascending dose studies were required, with precise control over delivered dose. The challenge was that the medicine had an unusually wide safety margin, requiring delivery across a very broad dosing range. Designing a formulation, dosing, and delivery strategy capable of achieving this level of control presented a significant development challenge.
How we
found a way
We developed a novel aliquoting regime combined with a carefully designed clinical dosing strategy to enable accurate and reproducible dose escalation. Using a breath actuated nebulisation approach, the medicine was delivered one breath at a time, allowing controlled micro dosing of each subject.
This integrated formulation and trial design approach enabled safe progression into first in human studies across the required dose range. The client was able to move forward with confidence, knowing their medicine was being delivered safely, precisely, and effectively.
Go with ABINITIO
Whether you need us for the whole path, or just one part, we deliver what matters most: progress.
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