[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557545":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":60,"studyPopulation":48,"armGroups":61,"interventions":88,"overallOfficials":48,"centralContacts":98,"locations":104,"responsibleParty":282,"collaborators":48,"id":284,"slug":48,"hasResults":285,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":48,"eligibilityCriteria":289,"healthyVolunteers":290,"sex":291,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":48,"studyType":297,"phases":298,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":130,"whyStopped":48,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},{"fullName":5,"class":6},"BioCryst Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":48},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-emergent adverse events (TEAEs)","Incidence of TEAEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) from screening through end-of-study (EOS) in each study part","From screening through EOS (ie, through Day 78 in Parts 1 and 3, and Day 106 in Part 2)",{"measure":14,"description":15,"timeFrame":16},"Change from baseline in Ichthyosis Area and Severity Index (IASI) score at Week 12 (Part 4)","IASI measures the severity of erythema (IASI-E) and scaling (IASI-S); the maximum sub-scores for the IASI-E and IASI-S being 24, and the maximum total IASI score being 48. Higher scores indicate worse clinical outcome.","From baseline to Week 12",[18,22,25,28,31,35,38,41,45],{"measure":19,"description":20,"timeFrame":21},"Maximum observed serum concentration (Cmax)","Cmax of BCX17725","Up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)",{"measure":23,"description":24,"timeFrame":21},"Time to maximum observed serum concentration (Tmax)","Time to Cmax of BCX17725",{"measure":26,"description":27,"timeFrame":21},"Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUC0-t)","AUC0-t of BCX17725",{"measure":29,"description":30,"timeFrame":21},"Terminal elimination half-life (t1\u002F2)","Terminal elimination half-life (t1\u002F2) of BCX17725",{"measure":32,"description":33,"timeFrame":34},"Number of participants who are anti-drug antibody (ADA)-positive (baseline and post-baseline) and number of participants who have treatment-emergent ADAs","Incidence of ADAs to BCX17725","Day 1 pre-dose and up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)",{"measure":36,"description":37,"timeFrame":16},"Change from baseline in Investigator Global Assessment (IGA) score at Week 12 (Part 4)","IGA assesses the overall severity of a participant's NS skin disease based on a 5-point scale (0, clear; 1, almost clear; 2, mild; 3, moderate; and 4, severe). Higher scores indicate worse clinical outcome.",{"measure":39,"description":40,"timeFrame":16},"Change from baseline in Worst Itch Numerical Rating Score (NRS) at Week 12 (Part 4)","Worst Itch Numerical Rating Scale (NRS) is a self-rated, single-item scale designed for assessing the worst itch in the past 7 days. The scale uses an 11-point NRS, scored from 0 (no itch) to 10 (worst possible itch). Higher scores indicate worse clinical outcome.",{"measure":42,"description":43,"timeFrame":44},"Incidence of TEAEs (Part 4)","Incidence of TEAEs as assessed by CTCAE","From baseline through Week 20",{"measure":46,"description":47,"timeFrame":44},"Serum concentrations of BCX17725 (Part 4)","Serum concentrations of BCX17725",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":48,"timePerspective":48,"maskingInfo":54},"RANDOMIZED","SEQUENTIAL","In Parts 1 and 2, participants will be randomized to BCX17725 or placebo under double-blind conditions. In Parts 3 and 4, participants will receive open-label BCX17725.","TREATMENT",{"masking":55,"maskingDescription":56,"whoMasked":57},"DOUBLE","Parts 1 and 2 will be blinded; Parts 3 and 4 will be open label",[58,59],"PARTICIPANT","INVESTIGATOR","Parts 1 and 2 are randomized, placebo-controlled, single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study parts, respectively, in healthy participants. Part 3 will evaluate multiple dose administrations in participants with Netherton syndrome in an open-label design. Part 4 will evaluate multiple administrations of BCX17725 in participants with Netherton syndrome in an open-label study design over 12 weeks, with an 8-week post-treatment follow-up period.",[62,68,73,77,81,85],{"label":63,"type":64,"description":65,"interventionNames":66},"Part 1 - BCX17725 single dose","EXPERIMENTAL","Participants randomized to BCX17725 will receive BCX17725 as a single dose in sequential ascending dose cohorts",[67],"Drug: BCX17725",{"label":69,"type":64,"description":70,"interventionNames":71},"Part 1 - placebo single dose","Participants randomized to placebo will receive placebo as a single dose",[72],"Drug: Placebo",{"label":74,"type":64,"description":75,"interventionNames":76},"Part 2 - BCX17725 multiple doses","Participants randomized to BCX17725 will receive BCX17725 as multiple doses in sequential ascending dose cohorts",[67],{"label":78,"type":64,"description":79,"interventionNames":80},"Part 2 - placebo multiple doses","Participants randomized to placebo will receive placebo as multiple doses",[72],{"label":82,"type":64,"description":83,"interventionNames":84},"Part 3 - BCX17725 multiple doses","Participants will receive BCX17725 as multiple doses",[67],{"label":86,"type":64,"description":83,"interventionNames":87},"Part 4 - BCX17725 multiple doses",[67],[89,94],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":48},"DRUG","BCX17725","BCX17725 for injection",[63,74,82,86],{"type":90,"name":95,"description":96,"armGroupLabels":97,"otherNames":48},"Placebo","Placebo for injection",[69,78],[99],{"name":100,"role":101,"phone":102,"phoneExt":48,"email":103},"BioCryst Pharmaceuticals, Inc.","CONTACT","+1 919 859 1302","clinicaltrials@biocryst.com",[105,128,144,159,173,189,206,217,228,247,258,273],{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Stanford University School of Medicine","NOT_YET_RECRUITING","Palo Alto","California","94304","United States","US",{"type":114,"coordinates":115},"Point",[116,117],-122.14302,37.44188,{"lat":117,"lon":116},[120,124],{"name":121,"role":101,"phone":122,"phoneExt":48,"email":123},"Chaw-Ning Lee","650-497-7230","cnlee06@stanford.edu",{"name":125,"role":101,"phone":126,"phoneExt":48,"email":127},"Thomas Buschbacher","352-278-7603","tbusch@stanford.edu",{"facility":129,"status":130,"city":131,"state":109,"zip":132,"country":111,"countryCode":112,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Therapeutics Clinical Research","RECRUITING","San Diego","92123",{"type":114,"coordinates":134},[135,136],-117.16472,32.71571,{"lat":136,"lon":135},[139],{"name":140,"role":101,"phone":141,"phoneExt":142,"email":143},"Hector Bailon","858-571-6800","141","hbailon@therapeuticsresearch.com",{"facility":145,"status":130,"city":146,"state":147,"zip":148,"country":111,"countryCode":112,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Yale Center for Clinical Investigation","New Haven","Connecticut","06519",{"type":114,"coordinates":150},[151,152],-72.92816,41.30815,{"lat":152,"lon":151},[155],{"name":156,"role":101,"phone":157,"phoneExt":48,"email":158},"Nicole Olszewski","203-785-5505","nicole.olszewski@yale.edu",{"facility":160,"status":130,"city":161,"state":162,"zip":163,"country":111,"countryCode":112,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Northwestern Dermatology CTU","Chicago","Illinois","60611",{"type":114,"coordinates":165},[166,167],-87.65005,41.85003,{"lat":167,"lon":166},[170],{"name":48,"role":101,"phone":171,"phoneExt":48,"email":172},"312-503-5944","NUderm-research@northwestern.edu",{"facility":174,"status":130,"city":175,"state":176,"zip":177,"country":111,"countryCode":112,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Dawes Fretzin Clinical Research Group, LLC","Indianapolis","Indiana","46250",{"type":114,"coordinates":179},[180,181],-86.15804,39.76838,{"lat":181,"lon":180},[184],{"name":185,"role":101,"phone":186,"phoneExt":187,"email":188},"Joannie Prusa","317-516-5030","108","jprusa@ecommunity.com",{"facility":190,"status":130,"city":191,"state":192,"zip":193,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Westmead Hospital - Department of Dermatology","Sydney","New South Wales","2145","Australia","AU",{"type":114,"coordinates":197},[198,199],151.20732,-33.86785,{"lat":199,"lon":198},[202],{"name":203,"role":101,"phone":204,"phoneExt":48,"email":205},"Pablo Fernandez-Penas, MD","02 8890 5686","wslhd-dermatology-clinicaltrials@health.nsw.gov.au",{"facility":207,"status":208,"city":209,"state":210,"zip":211,"country":194,"countryCode":195,"cosmosGeoPoint":212,"geoPoint":216,"contacts":48},"Nucleus Network","COMPLETED","Brisbane","Queensland","4006",{"type":114,"coordinates":213},[214,215],153.02809,-27.46794,{"lat":215,"lon":214},{"facility":218,"status":130,"city":209,"state":210,"zip":219,"country":194,"countryCode":195,"cosmosGeoPoint":220,"geoPoint":222,"contacts":223},"Veracity Clinical Research","4102",{"type":114,"coordinates":221},[214,215],{"lat":215,"lon":214},[224],{"name":225,"role":101,"phone":226,"phoneExt":48,"email":227},"Lynda Spelman, MD","07 3039 1311","trials@veracityclinicalresearch.com.au",{"facility":229,"status":130,"city":230,"state":48,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Hôpital Saint-Louis","Paris","75010","France","FR",{"type":114,"coordinates":235},[236,237],2.3488,48.85341,{"lat":237,"lon":236},[240,244],{"name":241,"role":101,"phone":242,"phoneExt":48,"email":243},"Emilie Fapong","01 42 49 40 62","emilie.fapong@aphp.fr",{"name":245,"role":101,"phone":242,"phoneExt":48,"email":246},"Hafsoiti Hassandjohar","hafsoiti.hassandjohar@aphp.fr",{"facility":248,"status":107,"city":249,"state":48,"zip":250,"country":251,"countryCode":252,"cosmosGeoPoint":253,"geoPoint":257,"contacts":48},"Universitätsklinikum Heidelberg","Heidelberg","69120","Germany","DE",{"type":114,"coordinates":254},[255,256],8.69079,49.40768,{"lat":256,"lon":255},{"facility":259,"status":130,"city":260,"state":48,"zip":261,"country":262,"countryCode":263,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Maastricht Universitair Medisch Centrum (MUMC+)","Maastricht","6229 HX","Netherlands","NL",{"type":114,"coordinates":265},[266,267],5.68889,50.84833,{"lat":267,"lon":266},[270],{"name":48,"role":101,"phone":271,"phoneExt":48,"email":272},"+31 (0)43-3875290","genodermatose@mumc.nl",{"facility":274,"status":130,"city":275,"state":48,"zip":276,"country":262,"countryCode":263,"cosmosGeoPoint":277,"geoPoint":281,"contacts":48},"Erasmus Universitair Medisch Centrum (EMC)","Rotterdam","3015 GD",{"type":114,"coordinates":278},[279,280],4.47917,51.9225,{"lat":280,"lon":279},{"type":283,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100557545",false,"NCT06539507","A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725","A Phase 1\u002F1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of BCX17725 in Healthy Participants and Multiple Doses of BCX17725 in Participants With Netherton Syndrome","Key Inclusion Criteria:\n\n* Male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (Parts 1 and 2), 18 to 65 years, inclusive (Part 3), or 12 to 65 years, inclusive (Part 4)\n* Confirmed diagnosis of Netherton syndrome (Parts 3 and 4)\n* IGA score of ≥ 3 (Parts 3 and 4) and IASI score of ≥ 16 (Part 4)\n* BMI between 18 and 30 kg\u002Fm\\^2, inclusive (Parts 1 and 2)\n* Estimated glomerular filtration rate (eGFR) of ≥ 90 mL\u002Fmin\u002F1.73 m\\^2 (Parts 1 and 2) or ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 (Part 3)\n* Agree to follow the protocol contraception requirements from screening until 90 days after the last dose of study drug\n* In the opinion of the investigator, expected to adequately comply with all required study procedures and restrictions for the duration of the study",true,"ALL","12 Years","65 Years",{"count":295,"type":296},78,"ESTIMATED","INTERVENTIONAL",[299],"PHASE1","This is a first-in-human, Phase 1\u002F1b, 4-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult participants (Parts 1 and 2), and multiple doses in adult participants with Netherton syndrome (Part 3). In Part 4, the effectiveness, safety, and tolerability of BCX17725 when administered via multiple IV and\u002For SC doses through 12 weeks will be evaluated in adult and adolescent participants with Netherton syndrome.",[302],"Netherton Syndrome",[304,305,306,307,308,309],"First-in-human","Single ascending dose","Multiple ascending dose","Pharmacokinetics","Placebo control","Netherton syndrome","2026-06-15",{"date":312,"type":313},"2026-06-16","ACTUAL",{"date":315,"type":313},"2024-09-26",{"date":317,"type":296},"2026-12",{"name":5,"class":6},12]