A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis

This first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-001. Part C will assess BYN-001 in adults with moderate to severe atopic dermatitis.

Part A and B Key Inclusion Criteria: * Age 18-55 years of age * Must be in good health with no significant medical conditions * Willing and able to attend all study visits and comply with study requirements * Able and willing to provide written informed consent Part A and B Exclusion Criteria: * Evidence of clinically significant condition or disease * Any physical or psychosocial condition that prohibits study completion * Know history of illicit drug use or abuse, alcoholism and/or smoking more than -5 cigarettes a day in the prior 3 months * History of sever allergic reactions of hypersensitivity Part C Inclusion Criteria * Age 18-55 years of age * Must be in good health with no significant medical conditions * Willing and able to attend all study visits and comply with study requirements * Able and willing to provide written informed consent * Documented chromic atopic dermatitis within 1 year prior to screening * Moderate to severe atopic dermatitis Part C Key Exclusion Criteria * Evidence of clinically significant condition or disease * Any physical or psychosocial condition that prohibits study completion * Know history of illicit drug use or abuse, alcoholism and/or smoking more than 5 cigarettes a day in the prior 3 months * History of sever allergic reactions of hypersensitivity * Incomplete washout of prior atopic dermatitis medications * Other confounding skin diseases