The ascending dose, double-blind, placebo-controlled study in healthy, non-smoking and smoking volunteers is designed to demonstrate the safety, tolerability and pharmacodynamic profile of the drug candidate.
The study will also assess vaccine’s potency through the measurement of concentrations of nicotine-specific antibodies.
SEL-068 is fully synthetic nanoparticle vaccine and the high antibody concentrations induced by it have the potential to absorb inhaled nicotine, preventing it from reaching the brain and triggering the addictive response.
Selecta president and CEO Werner Cautreels said by entering into Phase 1 human clinical studies, the company has demonstrated its capability to scale production and demonstrate safety in toxicology studies.
"We can now accelerate the development of our platform and bring forward our candidates in autoimmune, infectious diseases and cancer," Cautreels said.