Clinical proof of concept in first-in-human study

PBMC isolation

The Client

A small start-up company wishing to demonstrate their drug’s unique selling points in a first-in-human study.

The Challenge

The drug was a novel agent with unique pharmacokinetic and pharmacodynamic properties. This start-up client wished to demonstrate these properties using customised assays in series of single ascending dose and multiple ascending dose studies.

The phase I clinical research organisation sought out Java’s expertise to develop and implement these assays alongside standard phase I safety and pharmacokinetic assays.

The Approach 

Based on the client’s initial specification, Java rapidly produced a feasibility study outlining how we could address the client’s needs.

Java’s presentation detailing our proposed development and implementation of the customised assays was crucial to securing the contract at a joint bid defence with the phase I CRO.

Working to tight timelines, we developed methods based on state-of-the-art laboratory procedures to isolate the drug’s target cells from blood and measure drug accumulation therein, to demonstrate a unique pharmacokinetic effect.

We also developed assays based on the client’s preclinical work to demonstrate specific pharmacodynamic effects in samples from this phase I study.

The Outcome

Java scientists worked effectively alongside staff from the phase I CRO to implement three customised assays alongside standard clinical trial procedures.

Results of the assays were rapidly reported to inform dosing decisions for successive cohorts.

Java’s assays demonstrated clinical proof of concept in a first-in-human study.

During this study the start-up company sold the compound to a top-ten pharma company for future development.