A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects

1st Biotherapeutics, Inc.
Study Design: 
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the active drug, FB-101. The study has two parts where the drug will be administered in single and multiple ascending doses. 48 healthy adults aged between 19 to 55 years will be included. Standard inclusion and exclusionary criteria apply. The study is being conducted in Baltimore, USA.
The primary outcome measures the number and severity of treatment-emergent adverse events seven days after the last dose. The secondary outcome will measure the peak plasma concentration and area under the curve of FB-101.
FB-101 is another c-Abl kinase inhibitor being introduced to the gamut of kinase inhibitors. There is a lack of available preclinical data at this time. The molecule is still in the early stages. The current study is a phase 1 trial in younger healthy volunteers with no assessment of BBB penetrance. Safety, tolerability, and efficacy in the PD population are yet to be explored. The study is listed to have been completed in June 2020, but no updates have been provided on clinicaltrials.gov or the company website. The delay could have been in the setting of the COVID-19 pandemic. Further news and data are awaited.