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NCT Number: NCT07746817

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Healthy Participants Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Pharmacokinetic parameters of BYN-001

    Time frame: Serial PK sampling per the Schedule of Assessments, through Week 48

    Peak plasma concentration of BYN-001 may be calculated if deemed necessary.

  2. Incidence of anti-drug antibodies (ADA) to BYN-001

    Time frame: Baseline through Week 48

    Immunogenicity assessed using a validated methods.

  3. Pharmacokinetic parameters of BYN-001

    Time frame: Serial PK sampling per the Schedule of Assessments, through Week 48

    Area under the curve of BYN-001 may be calculated if deemed necessary.

  4. Titer of anti-drug antibodies (ADA) to BYN-001

    Time frame: Baseline through Week 48

    Immunogenicity assessed using validated methods.

Study contacts

Contact information is provided by the study sponsor or research team.

James McCarthy, Prof.

CONTACT

[email protected]

+61 3 9970 4200

Sponsors and collaborators

Lead sponsor

Bionyra Pharma

Industry

Registry information

Official study 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

Acronym: BYN-001-101

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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