NCT07746817 A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
| NCT ID | NCT07746817 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bionyra Pharma |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-08-17 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2026-08-17 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07746817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07746817 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07746817 currently recruiting?
Yes, NCT07746817 is actively recruiting participants. Contact the research team at jmccarthy@dohertyclinicaltrials.com for enrollment information.
Where is the NCT07746817 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT07746817 clinical trial?
NCT07746817 is sponsored by Bionyra Pharma. The trial plans to enroll 56 participants.
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