A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BYN-001
Biological/VaccineBYN-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
DrugPart 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.
Treatment groups
56 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Experimental, Part A, SAD Cohorts: BYN-001 Active drugExperimental treatment 1 intervention
Group B: Placebo Comparator, Part A, SAD Cohorts PlaceboPlacebo comparator 1 intervention
Group C: Experimental, Part B, MAD Cohorts: BYN-001 Active drugExperimental treatment 1 intervention
Group D: Placebo Comparator Part B, MAD Cohorts: BYN-001 PlaceboPlacebo comparator 1 intervention
Group E: Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001Experimental treatment 1 intervention
Group F: Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
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 outcomes
1
Pharmacokinetic parameters of BYN-001
Peak plasma concentration of BYN-001 may be calculated if deemed necessary.
Time frame
Serial PK sampling per the Schedule of Assessments, through Week 482
Incidence of anti-drug antibodies (ADA) to BYN-001
Immunogenicity assessed using a validated methods.
Time frame
Baseline through Week 483
Pharmacokinetic parameters of BYN-001
Area under the curve of BYN-001 may be calculated if deemed necessary.
Time frame
Serial PK sampling per the Schedule of Assessments, through Week 484
Titer of anti-drug antibodies (ADA) to BYN-001
Immunogenicity assessed using validated methods.
Time frame
Baseline through Week 48Sponsors and contacts
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Source ClinicalTrials.gov