[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658176":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":34,"studyPopulation":11,"armGroups":35,"interventions":56,"overallOfficials":66,"centralContacts":70,"locations":76,"responsibleParty":91,"collaborators":11,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":11,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":11,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Harmony Biosciences Management, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Mean Sleep Latency as Assessed by Maintenance of Wakefulness Test (MWT)",null,"Day 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).",{"measure":14,"description":11,"timeFrame":15},"Karolinska Sleepiness Scale (KSS) Score","Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).",{"measure":17,"description":11,"timeFrame":15},"Psychomotor Vigilance Test (PVT) Score",[19,22],{"measure":20,"description":11,"timeFrame":21},"Number of Participants with Treatment Emergent Adverse Events","Up to 25 weeks",{"measure":23,"description":11,"timeFrame":24},"Serum Concentrations of HBS-104 and Metabolites","Days 1, 2 and 3 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).",{"allocation":26,"interventionModel":27,"interventionModelDescription":11,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":30,"maskingDescription":11,"whoMasked":31},"DOUBLE",[32,33],"PARTICIPANT","INVESTIGATOR","Single oral doses of HBS-104 (low, medium or high doses) or matching placebo will be administered in 4 double-blind treatment periods in a crossover design. Each treatment period is 4 days in duration (Days -1 to 3) separated by a 7 to 12 day washout interval.",[36,42,46,50],{"label":37,"type":38,"description":39,"interventionNames":40},"Crossover: HBS-104 Low Dose","EXPERIMENTAL","Participants will receive a single oral low dose of HBS-104.",[41],"Drug: HBS-104",{"label":43,"type":38,"description":44,"interventionNames":45},"Crossover: HBS-104 Medium Dose","Participants will receive a single oral medium dose of HBS-104.",[41],{"label":47,"type":38,"description":48,"interventionNames":49},"Crossover: HBS-104 High Dose","Participants will receive a single oral high dose of HBS-104.",[41],{"label":51,"type":52,"description":53,"interventionNames":54},"Crossover: Placebo","ACTIVE_COMPARATOR","Participants will receive a single oral dose of placebo.",[55],"Drug: Placebo",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DRUG","HBS-104","Immediate-release tablets for oral use",[47,37,43],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"Placebo","Matching placebo tablet",[51],[67],{"name":68,"affiliation":5,"role":69},"David Sneiden, MD","STUDY_DIRECTOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":11,"email":75},"Clinical Trials Administrator","CONTACT","see email","clinicaltrials@harmonybiosciences.com",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":11},"Sponsor Clinical Site - New Jersey","RECRUITING","Eatontown","New Jersey","07724","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-74.05097,40.29622,{"lat":89,"lon":88},{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658176","phase-1-study-of-single-doses-of-hbs-104-in-acutely-sleep-deprived-healthy-participants-100658176",false,"NCT07848659","Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants","A Randomized, Double-blind, Placebo-controlled Crossover Study of the Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Single Doses of HBS 104 in Acutely Sleep-deprived Healthy Participants","Inclusion Criteria:\n\n* Provide written informed consent before any study-related procedures are performed.\n* Be healthy as determined by assessments at the Screening Visit.\n\nExclusion Criteria:\n\n* Female with a positive pregnancy test at Screening Visit or upon check-in for Period 1.\n* Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 7 days after their final dose of study drug.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol",true,"ALL","18 Years","55 Years",{"count":105,"type":106},12,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.",[112],"Sleep Deprivation",[114,115],"Healthy Participants","Acute Sleep Deprivation","2026-09-23",{"date":118,"type":119},"2026-09-30","ACTUAL",{"date":121,"type":119},"2026-08-28",{"date":123,"type":106},"2027-02-18",{"name":5,"class":6},1]