BYN-001: BYN-001 will be administered by subcutaneous injection. In Part A, a Single Ascending Dose (SAD) design will be implemented across up to five cohorts, with healthy participants receiving a single dose of BYN-001. In Part B, a Multiple Ascending Dose (MAD) design will be implemented with healthy participants receiving multiple doses of BYN-001.
Placebo: Part A SAD healthy participants will receive a single subcutaneous injection of placebo. Part B MAD healthy participants will receive multiple doses of subcutaneous injection of placebo.
Study 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
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Incidence and severity of adverse events (AEs) — From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients) Includes clinically relevant findings from clinical laboratory tests (haematology, urinalysis, blood chemistry), physical examination, vital signs, and 12-lead ECG. Assessed separately for the healthy-volunteer participants (Part A and B) and the AD participants in Part C.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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