Safety of BYN-001 in healthy adults and adults with atopic dermatitis
Tests the antibody BYN-001 in healthy adults and adults with moderate to severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 55. Healthy adults can join Parts A and B. Adults with moderate to severe atopic dermatitis can join Part C.
- Age
- 18 to 55 years
- Sex
- Women and men can join.
- Disease stage
- Parts A and B: no significant medical conditions. Part C: moderate to severe atopic dermatitis, documented within 1 year before screening.
- Earlier treatment
- Part C: earlier atopic dermatitis medicines must be fully washed out before joining.
Main reasons for not taking part
- A clinically significant condition or disease
- A physical or psychosocial condition that prevents finishing the study
- History of illicit drug use or abuse, alcoholism, or smoking more than 5 cigarettes a day in the past 3 months
- History of severe allergic reactions
- Part C: other skin diseases that could confuse the results
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07746817, who can take part
Where in Australia
- Doherty Clinical TrialsMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Bionyra Pharma
- Trial code
- NCT07746817
- Record updated
- 30 September 2026
- Original 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.Read full original descriptionShow less
A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BYN-001 in Healthy Adult Participants and Participants With Moderate to Severe Atopic Dermatitis
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.
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.