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

ConditionsAtopic Dermatitis Healthy Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorBionyra Pharma

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

BYN-001
Placebo

Treatment groups

56 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

Bionyra Pharma

Lead sponsor

Source ClinicalTrials.gov