[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bionyra Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"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":22,"type":23},56,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30],"Atopic Dermatitis","Healthy Participants",[32,33,34,35,36,37,38],"IL-25","Monoclonal antibody","First-in-human","Multiple ascending dose","Single ascending dose","Atopic dermatitis","Healthy Participant","NOT_YET_RECRUITING","2026-08-05",{"date":42,"type":43},"2026-08-07","ACTUAL",{"date":45,"type":23},"2026-08-01",{"date":47,"type":23},"2028-12-31",{"name":49,"class":50},"Bionyra Pharma","INDUSTRY",""]