[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650380":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":42,"centralContacts":48,"locations":42,"responsibleParty":54,"collaborators":42,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":42,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":86,"whyStopped":42,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},{"fullName":5,"class":6},"Bionyra Pharma","INDUSTRY",[8,14,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Biological: BYN-001",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator, Part A, SAD Cohorts Placebo","PLACEBO_COMPARATOR","Healthy participants will receive a single dose of placebo comparator",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Experimental, Part B, MAD Cohorts: BYN-001 Active drug","Healthy participants will receive a repeated doses of BYN-001 in a dose escalation format",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo","Healthy participants will receive repeated doses of placebo comparator",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001","Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of BYN-001",[13],{"label":33,"type":16,"description":34,"interventionNames":35},"Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo","Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of placebo",[19],[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BIOLOGICAL","BYN-001","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.",[9,21,29],null,{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":42},"DRUG","Placebo","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.",[25,15,33],[49],{"name":50,"role":51,"phone":52,"phoneExt":42,"email":53},"James McCarthy, Prof.","CONTACT","+61 3 9970 4200","jmccarthy@dohertyclinicaltrials.com",{"type":55,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100650380","phase-1-a-study-of-byn-001-in-healthy-adults-and-in-adults-with-moderate-to-severe-atopic-dermatitis-100650380",false,"NCT07746817","A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis","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","BYN-001-101","Part A and B Key Inclusion Criteria:\n\n* Age 18-55 years of age\n* Must be in good health with no significant medical conditions\n* Willing and able to attend all study visits and comply with study requirements\n* Able and willing to provide written informed consent\n\nPart A and B Exclusion Criteria:\n\n* Evidence of clinically significant condition or disease\n* Any physical or psychosocial condition that prohibits study completion\n* Know history of illicit drug use or abuse, alcoholism and\u002For smoking more than -5 cigarettes a day in the prior 3 months\n* History of sever allergic reactions of hypersensitivity\n\nPart C Inclusion Criteria\n\n* Age 18-55 years of age\n* Must be in good health with no significant medical conditions\n* Willing and able to attend all study visits and comply with study requirements\n* Able and willing to provide written informed consent\n* Documented chromic atopic dermatitis within 1 year prior to screening\n* Moderate to severe atopic dermatitis\n\nPart C Key Exclusion Criteria\n\n* Evidence of clinically significant condition or disease\n* Any physical or psychosocial condition that prohibits study completion\n* Know history of illicit drug use or abuse, alcoholism and\u002For smoking more than 5 cigarettes a day in the prior 3 months\n* History of sever allergic reactions of hypersensitivity\n* Incomplete washout of prior atopic dermatitis medications\n* Other confounding skin diseases",true,"ALL","18 Years","55 Years",{"count":69,"type":70},56,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","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.",[76,77],"Atopic Dermatitis","Healthy Participants",[79,80,81,82,83,84,85],"IL-25","Monoclonal antibody","First-in-human","Multiple ascending dose","Single ascending dose","Atopic dermatitis","Healthy Participant","NOT_YET_RECRUITING","2026-08-05",{"date":89,"type":90},"2026-08-07","ACTUAL",{"date":92,"type":70},"2026-08-01",{"date":94,"type":70},"2028-12-31",{"name":5,"class":6}]