A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis (NCT07746817) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
56 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events (AEs)
Timeframe: From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients)