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.

NCT Number	NCT07746817
Lead Sponsor	Bionyra Pharma
Conditions	Atopic Dermatitis, Healthy Participants
Enrollment	56 participants
Start Date	2026-08-01
Primary Completion	2028-06-01 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-07