RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Bionyra Pharma • ClinicalTrials.gov ID: NCT07746817

Registry updated: 2026-09-30

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

BYN-001 (Biological)
BYN-001 will be administered by subcutaneous injection. In Part A, a Single Ascending Dose (SAD) design will be implemented across up to five cohorts, with healthy participants receiving a single dose of BYN-001. In Part B, a Multiple Ascending Dose (MAD) design will be implemented with healthy participants receiving multiple doses of BYN-001.
Placebo (Drug)
Part A SAD healthy participants will receive a single subcutaneous injection of placebo. Part B MAD healthy participants will receive multiple doses of subcutaneous injection of placebo.

Eligibility criteria

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

Conditions

Atopic Dermatitis Healthy Participants

Locations

Doherty Clinical Trials — Melbourne, Victoria, Australia

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment