NCT07746817RecruitingPhase 1
A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 9 Jul 2026
- Start date
- 17 Aug 2026
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Bionyra Pharma
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07746817
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 56
- From 17 Aug 2026 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Doherty Clinical Trials Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.