A Phase 1 Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis | NCT07746817

NCT07746817

Overview

NCT ID: NCT07746817
Lead Sponsor: Bionyra PharmaINDUSTRY
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
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Jun 1, 2028Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 56Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: James McCarthy, Prof.Contact
jmccarthy@dohertyclinicaltrials.com

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