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A Phase 1 Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
Sponsor: Bionyra Pharma
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-08-01
Completion Date
2028-12-31
Last Updated
2026-08-05
Healthy Volunteers
Yes
Conditions
Interventions
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.