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

Sponsor
Bionyra Pharma
Study ID
NCT07746817
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BYN-001 — BIOLOGICAL
    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 — DRUG
    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 Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental, Part A, SAD Cohorts: BYN-001 Active drug
    Healthy participants will receive a single dose of BYN-001 in a dose escalation format
  • Placebo Comparator: Placebo Comparator, Part A, SAD Cohorts Placebo
    Healthy participants will receive a single dose of placebo comparator
  • Experimental: Experimental, Part B, MAD Cohorts: BYN-001 Active drug
    Healthy participants will receive a repeated doses of BYN-001 in a dose escalation format
  • Placebo Comparator: Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo
    Healthy participants will receive repeated doses of placebo comparator
  • Experimental: Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001
    Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of BYN-001
  • Placebo Comparator: Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo
    Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of placebo

Primary Outcome Measure

Incidence and severity of adverse events (AEs) [ Time Frame: From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients) ]

Central Contacts

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