The drug candidate LIB-01
The goal for the development of LIB-01 is to become a registered drug. A preclinical development program is currently underway, studying the pharmacology and kinetics of the drug substance as well as a comprehensive safety evaluation in order to investigate possible toxic effects in LIB-01. Within the development program, process development and manufacturing are also carried out to ensure availability of the drug substance. The drug substance together with a formulation, constitute the drug product that will be used in the first clinical human trial. All of these preclinical activities must be completed before the application to begin a Phase 1 clinical trial can be compiled.
Preliminary development plan