BYN-001 in healthy adults and adults with moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, phase 1 trial of BYN-001, a humanized IgG1 antibody that neutralizes interleukin-25. Parts A and B enroll healthy adults in single ascending and multiple ascending dose cohorts to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity under a sentinel-design with an independent Safety Monitoring Committee. Part C expands to adults with moderate to severe atopic dermatitis to explore safety and pharmacology in the target condition. BYN-001 is designed to block IL-25 and potentially reduce type 2 inflammatory signaling and pruritus. The study uses placebo-controlled comparisons and aims to define appropriate dosing for future trials.

Why it matters

Who can join: the full rules

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

Where it's running

• Doherty Clinical Trials
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: James McCarthy, Prof.
• Email: jmccarthy@dohertyclinicaltrials.com
• Phone: +61 3 9970 4200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.