Illuminare Biotechnologies, a US-based privately held biotechnology company, announced on Monday that it has dosed its first subject in the phase one trial of Illuminare-1.

The product is being developed to improve the visualisation and delineation of critical nerve structures intra-operatively in real time with the intention of avoiding serious, and potentially permanent, unintended nerve injury.

The first-in-human clinical trial is being carried out at Memorial Sloan Kettering Cancer Center (MSK), jointly with collaborators from Illuminare Biotechnologies, in subjects undergoing robot-assisted radical prostatectomy.

The Phase 1 trial of Illuminare-1 is a dose-escalation study in up to 50 patients undergoing robot-assisted radical prostatectomy. The primary objective of the Phase 1 trial is safety, and secondary objectives include determination of the human pharmacokinetics of Illuminare-1 and selection of optimal dose based on fluorescence to advance in the clinic. The US FDA has granted Fast Track Designation to Illuminare-1.