On March 1st, 2023, the Phase I clinical trial Kick-Off Meeting of FB-1071, a category 1 new drug of 4B Technologies, was successfully held in Huashan Hospital affiliated to Fudan University.
FB-1071 is a potent, brain-penetrant, highly selective CSF-1R kinase inhibitor with global-first potentiality, which is intended to be developed for the treatment of Amyotrophic Lateral Sclerosis ( a life threatening rare neurodegenerative disease).
FB-1071 has been shown to delay motor function deterioration and prolong survival time in several ALS animal models. This clinical trial is a randomized, double-blind, placebo-controlled, single-ascending-dose study, led by Professor Zhang Jing of Huashan Hospital as Primary Investigator. The objectives are to evaluate the safety, pharmacokinetic/pharmacodynamic characteristics of FB-1071, as well as to examine food-effect, drug-drug interaction and identification of metabolites in healthy volunteers. Results of this trial will support the subsequent clinical study to evaluate safety and therapeutic efficacy in ALS patients.