- Quotient Sciences has initiated a Phase I clinical study in the UK evaluating an oral solid dose formulation developed using artificial intelligence.
- The study aims to assess safety and pharmacokinetics while evaluating the use of AI in formulation design and drug development decision-making.
Quotient Sciences announced the initiation of a Phase I clinical study evaluating an oral solid dose formulation developed using artificial intelligence. The study began at the company’s UK facility following approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
According to the company, the clinical trial will assess the safety and pharmacokinetics of the formulation in healthy volunteers. Quotient Sciences stated that a primary objective of the study is to evaluate the use of AI in drug product development and formulation design. The company said it believes this is the first reported case of an AI-designed formulation being evaluated in a clinical setting.
The AI-driven formulation development program combines machine learning with Quotient Sciences’ Translational Pharmaceutics platform to support formulation design and real-time clinical testing. The company stated that the approach is intended to support earlier and more informed development decisions while improving clinical predictability.
“This program marks a significant advancement in harnessing the power of advanced machine learning alongside deep scientific expertise to streamline drug development.”
Andy Lewis, Chief Scientific Officer at Quotient Sciences
Quotient Sciences stated that the formulation design process used machine learning technology from Intrepid Labs to evaluate formulation options and optimize expected clinical performance. The company also said the study represents part of a broader strategy to integrate AI-enabled approaches across formulation development and clinical workflows.
