A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis

Study acronym: BYN-001-101
StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2026 to Aug 17, 2026
    • Eligibility criteria expanded, about 20 words
  2. Study title shortened, about 2 wordsv2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07746817
Lead Sponsor Bionyra Pharma
Conditions
(from sponsor)		 Atopic Dermatitis, Healthy Participants
Related terms Dermatitis, Atopic
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov