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

RecruitingPhase 1Ages 18 Years - 55 YearsAllBionyra Pharma
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • BYN-001
  • Placebo
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Where

1 site
Doherty Clinical Trials
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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