A Phase 1 Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis

NCT07746817 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: BYN-001-101
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis; Healthy Participants

Keywords

IL-25; Monoclonal antibody; First-in-human; Multiple ascending dose; Single ascending dose; Atopic dermatitis; Healthy Participant

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  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.

  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 Outcomes (4)

• Pharmacokinetic parameters of BYN-001

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

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

  Baseline through Week 48

• Pharmacokinetic parameters of BYN-001

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

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

  Baseline through Week 48

Study Arms (6)

Experimental, Part A, SAD Cohorts: BYN-001 Active drug

EXPERIMENTAL

Healthy participants will receive a single dose of BYN-001 in a dose escalation format

Biological: BYN-001

Placebo Comparator, Part A, SAD Cohorts Placebo

PLACEBO COMPARATOR

Healthy participants will receive a single dose of placebo comparator

Drug: Placebo

Experimental, Part B, MAD Cohorts: BYN-001 Active drug

EXPERIMENTAL

Healthy participants will receive a repeated doses of BYN-001 in a dose escalation format

Biological: BYN-001

Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo

PLACEBO COMPARATOR

Healthy participants will receive repeated doses of placebo comparator

Drug: Placebo

Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001

EXPERIMENTAL

Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of BYN-001

Biological: BYN-001

Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo

PLACEBO COMPARATOR

Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of placebo

Drug: Placebo

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.

Experimental, Part A, SAD Cohorts: BYN-001 Active drug; Experimental, Part B, MAD Cohorts: BYN-001 Active drug; Experimental, Part C, Participants with mild to severe atopic dermatitis, 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.

Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo; Placebo Comparator, Part A, SAD Cohorts Placebo; Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Bionyra Pharma: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

James McCarthy, Prof.

CONTACT

+61 3 9970 4200; jmccarthy@dohertyclinicaltrials.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded study design. Site staff, participants and the Sponsor/CRO may become unblinded within 2 weeks of interim analysis completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share