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Not yet recruiting NCT07746817

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

Phase I Interventional Atopic Dermatitis Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BYN-001, Placebo.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Healthy Participants. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

Atopic dermatitis (AD) is a common chronic inflammatory skin disease for which current type 2 cytokine-targeted biologics leave a substantial proportion of patients with an inadequate response or residual pruritus. IL-25 acts upstream of type 2 inflammation and has been shown to drive pruritus and epidermal barrier dysfunction. BYN-001 selectively binds and neutralises IL-25 (with a long predicted terminal half-life), supporting an infrequent dosing interval.

Part A will consist of a single ascending dose (SAD) design, with administration in up to five cohorts. Part B will consist of a multiple ascending dose (MAD) design, with administration in up to three cohorts. Both parts will enroll healthy participants and will be conducted under a sentinel dosing approach, with dose escalation decisions governed by a Safety Monitoring Committee (SMC) at each escalation step.

Part C will enroll participants with moderate to severe AD.

Interventions

  • Biological 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.
  • Drug 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (4)
  • Pharmacokinetic parameters of BYN-001 [Time frame: Serial PK sampling per the Schedule of Assessments, through Week 48]
  • Incidence of anti-drug antibodies (ADA) to BYN-001 [Time frame: Baseline through Week 48]
  • Pharmacokinetic parameters of BYN-001 [Time frame: Serial PK sampling per the Schedule of Assessments, through Week 48]
  • Titer of anti-drug antibodies (ADA) to BYN-001 [Time frame: Baseline through Week 48]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746817 · BYN-001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗