Preparations for clinical Phase 1 studies

Before the application can be submitted to the relevant authorities to begin trials with LIB-01 in humans, Dicot is required to complete its comprehensive preclinical program and that all completed studies, including raw data, are carefully documented and available in summary reports. Attached to the application is an Investigational Brochure (IB) where all information concerning the preclinical tests, including safety evaluation and justification for deciding the starting dose for the test, will be clearly described and referred to. In addition, an Investigational Medicinal Product Dossier (IMPD) must be attached. This is a detailed description of the various manufacturing steps of LIB-01 and control of these, which leads to the final product. In a clinical trial, the final product is the investigational drug to be administered to the human candidates.

In addition to the above, the study itself must also include the choice of clinic and documentation of all various components. An example of this is the protocol of the clinical study, which must also be submitted in the application to the authorities to start Phase 1 trials. The entire study must be conducted according to the regulatory requirements which are stipulated in the Good Clinical Practice (GCP) standard.